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- 2026-03-16 21:30:23
- Company
- Novartis' application for voluntary retirement is closed
- by Sep 14, 2022 05:50am
- The application for ERP, which is underway by Novartis Korea, has ended. Attention is focusing on whether the relatively quiet voluntary retirement will be completed without any problems. According to the pharmaceutical industry on the 8th, the application for voluntary retirement, which was conducted by Novartis Korea for about two weeks, has recently been closed. The company announced the implementation of voluntary retirement on the 25th of last month. Novartis Korea is in the process of integrating and dividing its business units at the same time. The plan is to combine the Rx division and the anti-cancer drug division to unite innovative drugs into one and form a new division that collects patented drugs. New drugs such as Kymriah and Zolgensma are bound to be innovative drugs, and old drugs such as relatively low-cost chronic disease drugs are expected to be classified as patent expired drugs. ERP was also carried out in the process of integrating and dividing business units. The compensation condition is '2n+8' and additional compensation is given for each year. This means that an average salary of eight months is paid twice the number of years of service, and an additional six months' worth of employees for 10 to 15 years of service and 12 months' worth of employees for more than 15 years. It is reported that voluntary retirement is taking place in a relatively quiet atmosphere. It went through a meeting with the labor union before the announcement of his voluntary retirement, and it was found that it was not a coercive atmosphere because it did not specify the target. However, the key is how the company will respond if the applicant falls short of the desired retirement size the company thinks. The higher the number of years of service, the higher the desired retirement compensation. Last year, there was also a backlash against proceeding with voluntary retirement despite no management difficulties due to high profits. The NPU, which includes Novartis Korea, said at a meeting of National Assembly aides on the 7th, "Novartis is the world's most profitable pharmaceutical company last year, and this restructuring is also due to the unification of its business unit, not management reasons." The NPU said, "Novatis Korea also announced its voluntary retirement with a very passive attitude that it has no management difficulties, but has no choice but to follow global decisions." In the process, there is a concern about the risk of forced voluntary retirement, such as encouraging retirement, the NPU said. The union said, "There were some applicants for voluntary retirement, and the exact number of people is being determined. However, it remains to be seen how much the company thinks of voluntary retirement and whether it will make artificial adjustments beyond the legal part if they do not reach that level, he said. In response, the union said, "We have completed the application for voluntary retirement smoothly, and all procedures are conducted transparently and fairly in accordance with the law. The union said, "We will respect the will of our employees as much as possible and will not exercise compulsory pressure such as urging them to retire."
- Company
- Hanmi’s Rolontis receives US FDA marketing approval
- by Kim, Jin-Gu Sep 13, 2022 05:52am
- Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis (US product name: Rolvedon)' received approval from the US FDA. Hanmi Pharmaceutical and its partner Spectrum Pharmaceuticals announced on the 9th (local time) that it had received written notice of approval allowing for the marketing authorization of Rolontis from the FDA. This is the first new drug developed by Hanmi Pharmaceutical to be granted marketing authorization by the FDA. In terms of achievements made by the domestic biopharmaceutical industry, Hanmi Pharmaceutical’s approval this time marks the 6th new homegrown drug MA granted by the FDA and is the first among new anticancer drugs Hanmi Pharmaceutical and Spectrum Pharmaceuticals explained that they are ready to launch Rolontis in the US market. The companies expect to have the product available within the year based on the nationwide sales and marketing network they have established in the US. Se-Chang Kwon, President & CEO of Hanmi Pharmaceutical, said, “The approval holds significance as it is Hanmi’s first new drug to be granted approval and the first demonstration of the potential held by the company’s proprietary platform technology, LAPSCOVERY, The approval will be a decisive opportunity for the commercial success of Rolontis and the rise in the future value of new biologics based on LAPSCOVERY.
- Company
- Unilateral voluntary retirement
- by Sep 08, 2022 05:59am
- The GSK labor union of Korea has taken legal action, insisting on the management's unilateral voluntary retirement. The company is not taking any action, but the inside is "like the calm before the storm" as legal battles are predicted. Novartis Korea, where voluntary retirement is being carried out relatively quietly, is also nervous until the end. According to the pharmaceutical industry on the 8th, NPU's GSK branch recently filed an application with the Seoul Western Office of the Ministry of Employment and Labor and the Seoul Regional Labor Committee to file a petition for violation of the collective agreement and relieve unfair labor practices. It is claimed that the management violated the collective agreement and unilaterally proceeded with voluntary retirement. The union said, "According to Article 21 of the Korea Unification Association, in principle, it is necessary to agree with the union when the reduction is carried out due to unavoidable management circumstances. However, without any prior discussion, the management notified the union 30 minutes before the decision to reduce the number of employees and abruptly announced the voluntary retirement." Since then, they have pushed ahead with one-on-one meetings with employees, and they are putting psychological pressure on early applicants within a week by applying additional payment conditions. A union official added, "The decision is to make a legal judgment on HR's unfair labor practices and violations." It is reported that the management has not taken any action since the deadline for applications for voluntary retirement at the end of last month. Although the applicant did not meet the company's standards, there was no pressure or encouragement to meet the number of people. It is reported that there is no special response to the legal lawsuit filed by the union. Novartis Korea is better than this situation, a day before the deadline for voluntary retirement. Unlike GSK Korea, it has been consulted with the union and is found not to be coercive. Novartis Korea, the applicant union official said, " voluntary retirement and to understand the accurate number of people are. But the company's voluntary retirement is to think, how much remains to be part of what to do " said it would not.
- Company
- Sales of immuno-cancer drugs exceeded 200 billion won
- by Sep 08, 2022 05:58am
- In the first half of this year, the domestic immune anticancer drug market surpassed 200 billion won. In particular, Opdivo's performance, which showed his endurance, was remarkable. Opdivo sales increased 41% from the previous year, surpassing 50 billion won in half-year sales. According to IQVIA, a pharmaceutical market research firm, the size of the domestic immuno-cancer drug market in the first half of this year was 215.8 billion won, up 17.2% from 184.1 billion won a year earlier. The drug leading this market is MSD's Keytruda, which has the most indications. Keytruda posted 94.4 billion won in sales in the first half of this year, up 1.2% from the previous year. Sales seemed to be decreasing from the same period last year due to drug price cuts in the first quarter, but it turned upward again as benefits expanded in the second quarter, including primary treatment for non-small cell lung cancer. Currently, there are 15 cancers that can use Keytruda, including lung cancer, head and neck cancer, Hodgkin lymphoma, urinary epithelial cancer (Bladder cancer), esophageal cancer, melanoma, renal cell cancer, endometrial cancer, gastric cancer, small intestine cancer, ovarian cancer, pancreatic cancer, biliary cancer, colorectal cancer, and triple negative breast cancer. ◆Opdivo, which shows its endurance, surpasses 50 billion won in semi-annual prescriptions What stands out is Opdivo's rise. Opdivo sales in the first half of the year were 51.3 billion won, up 40.5% from 36.5 billion won a year earlier. The gap with Keytruda, which nearly tripled, has less than doubled. The market share of immuno-cancer drugs has also changed due to higher growth than Keytruda. Unlike last year, when Keytruda monopolized half of the total market, its share of Opdivo rose to 24% this year, reducing its share of Keytruda to 44%. Opdivo, developed by Ono and BMS, is an immuno-cancer drug licensed in Korea at the same time as Keytruda in 2015. It recorded sales similar to Keytruda until 2017, but the gap widened since 2018. This is because it has been relatively slow to expand indications and benefits compared to Keytruda, which aggressively increased indications. For this reason, Opdivo sales seemed to slow down between 2019 and 2020, but began to rise again from the end of last year. Opdivo, which stayed at 10 billion won for seven consecutive quarters from the fourth quarter of 2019, surpassed 20 billion won for the first time in the third quarter of last year. In the first and second quarters of this year, it settled in the mid-20 billion range with 25.1 billion won and 26.2 billion won, respectively. Opivo is expected to continue its upward trend as stomach cancer benefits are expected for the first time in an immuno-cancer drug. In June, the HIRA set Opdivo's standard for first-line gastric cancer treatment. Opdivo succeeded in re-challenging in about four months after suffering once in February. When the expansion process is completed, patients with HER2-negative stomach cancer will be able to use new drugs at low prices. HER2 negative gastric cancer patients account for nearly 90% of all patients, and there are no drugs other than Opdivo in the first treatment, so if it is expanded, it is expected to have a significant impact on sales. Yervoy, considered Opdivo's partner, also saw sales increase. Yervoy, which was only 1.3 billion won in the first half of last year, jumped to 6.1 billion won this year. Yervoy, the first immuno-cancer drug in Korea in the CTLA-4 family, is not well selected alone due to its limited effect and relatively high side effects. Instead, there is a combination therapy with Opdivo. Earlier this year, a combination therapy with Opdivo added a metastatic direct bowel cancer indication. ◆↑ 23% of Tecentriq & growth of Impinzi Roche Tecentriq and AstraZeneca Impinzi, generics of immuno-cancer drugs, are also steadily increasing their sales. It is Tecentriq which is showing greater performance. Tecentriq increased 22.6% year-on-year to 37.6 billion won in the first half of the year. During the same period, Impinzi increased 19.1% from 22.2 billion won to 26.4 billion won. Tecentriq succeeded in paying liver cancer for the first time among immuno-cancer drugs in April. The combination of Tecentriq and the targeted anticancer drug Avastin has become a standard treatment for liver cancer with excellent data beyond existing drugs. Analysts say that Tecentriq will gain momentum in expanding sales as it is prescribed for liver cancer in earnest. Impinzi is growing at a relatively slow pace this year with no special news. After surpassing 10 billion won for the first time in the first quarter of last year, quarterly sales remained in the early 10 billion range. Impinzi continues clinical trials in biliary tract cancer and liver cancer to expand further indications. Merck's Bavencio posted only 100 million won in sales in the first half of the year.
- Company
- Zolgensma, which is the same price as an apartment
- by Moon, sung-ho Sep 08, 2022 05:58am
- With ultra-high-priced treatments from global pharmaceutical companies newly entering the benefit range this year, human "risk management" is emerging as an issue at clinical sites. Since the treatment is so expensive, "risk" management issues such as damage and loss that may occur during administration are acting as a key issue. #Kymriah, the CAR-T treatment of Novartis Korea, which entered the benefit range this year, and Zolgensma, the treatment of Spinal Muscular Atrophy (SMA), are representative. According to the pharmaceutical industry and the medical community, Novartis Kymriah Korea has been applied as a health insurance benefit since April, and it has been confirmed that it has been administered not only at university hospitals in the Seoul metropolitan area but also at university hospitals in provincial areas. Zolgensma, who has newly entered the health insurance benefit zone since August, has passed the Drug Committee (DC) of major Big 5 hospitals, including Seoul National University Hospital and Seoul Asan Hospital, and is preparing to administer patients in earnest. As expensive treatments, which cost hundreds of millions of won alone, are administered in earnest at the clinical site, "risk management" that may occur is emerging as a key issue. For example, the question is who will be responsible for the damage or loss of the treatment in the process of handling patients with expensive treatments. This is because the price of the treatment is expensive, so both hospitals and pharmaceutical companies can be burdened depending on where they are responsible. Moreover, in Korea, it is recognized as a bigger problem because there is no insurance system that can be called a safety device in preparation for the human risk of such expensive treatments. However, there is a difference if Kymriah and Zolgensma are directly compared in terms of risk management. First of all, Kymriah, which entered the benefit range, is a pair due to the nature of the treatment, that is, a system that prepares two treatments in case of an emergency. An official from Novartis said, "In the case of Kymriah, due to the nature of the treatment, two treatments are prepared in case of an emergency." He explained the background, "As we make a treatment with T cells collected from the patient's blood, we can make two treatments with the same sauce." Kymriah reached up to 500 million won in the United States for a single administration, but in Korea, the patient's burden was lowered to up to 5.98 million won as it was set at 360.4 million won through drug price negotiations. Against this background, Um Ki-sung, a professor of blood medicine at Seoul St. Mary's Hospital, said, "In the process of introducing Kymriah, Novartis said that he would not receive drug costs if it was not actually administered, regardless of who did it wrong." Professor Um Ki-sung explained, "If a patient receives a lot of chemotherapy during the three-week administration, lymphocytes may not be extracted or cells may not come out." Professor Um said, "This means that pharmaceutical companies will not take issue with this and will only receive the drug price when the administration is completed." The problem is Zolgensma, which domestic drug price has been set at nearly 2 billion won. This is because the characteristics are different from Kymriah itself and there is no insurance system to prepare for risks that may occur during the administration process. In particular, in the case of Zolgensma, it is also worrisome that it differs from Kymriah in that the process is different, such as putting genes in vectors and transporting them so that they do not die. For this reason, there are opinions among large hospitals that are concerned about this. On top of that, Evrysdi, which is considering salaries as SMA treatments following Zolgensma, is also said to have to come up with a safety device for human risk. In this regard, the HIRA, which is considering benefits, reportedly asked pharmaceutical company Roche to come up with a plan. As Evrysdi is an oral drug, it means that safety devices should be prepared to prevent risk of patient loss. This is because Evrysdi will not have a high drug price compared to Zolgensma and Spinraza, but it is widely expected that it will be set as a burdensome drug price for patients. Novartis is in a position to discuss the plan with hospitals as it is scheduled to be administered in earnest according to the application of Zolgensma benefits. "Since it is an expensive treatment, it is not easy for hospitals and pharmaceutical companies to pay for it," a Novartis official said. "In the near future, Seoul National University Hospital is discussing how to manage risks and has been partially coordinated." "I think we will need to continue discussions in the future," he explained. He said, "I checked the insurance company in terms of human risk safety, but there is no insurance company that covers it." He added, "There is no internal determination of responsibility at the moment, but since it is the first time, we have to continue to discuss it in the future.".
- Company
- Godex’s price to be cut further under PVA
- by Nho, Byung Chul Sep 07, 2022 05:52am
- Celltrion Pharm’s liver disease treatment Godex cap. is experiencing ‘double trouble,’ being subject to Price-Volume Agreement negotiations after reimbursement reevaluations. According to industry sources, Godex’s price will be cut by ₩15 per capsule (4% reduction) from ₩371 to ₩356 as of the 1st of this month. Until now, Godex’s price had been discounted 11 times, from ₩434 in 2009 to ₩433 in 2011, to ₩431 in March 2016, to ₩422 in December 2016, to ₩422 in February 2017, to ₩413 in November 2017, to ₩402 in 2018, to ₩388 in 2019, to ₩376 in 2020, to ₩371 in 2021, to finally reach ₩356 in September this year. Godex, which was approved in Korea in 2000, is a combination of Biphenyldimethyldicarboxylate (main ingredient), Cyanocobalamin, Adenine Hcl, Carnitine Orotate, Pyridoxine Hcl, and antitoxic liver extract. Although its patent had become expired due to difficulty demonstrating bioequivalence, no generics have been released as of yet. The drug, which had enjoyed exclusivity in the market over the past 23 years due to this reason, is under adjustments after filing an appeal after the Health Insurance Reimbursement and Assessment Service failed to recognize the adequacy of its reimbursement during reevaluations, and its course of direction will be decided upon soon. In addition to the rise of such situational variables, Godex also became subject to management under the Price-Volume Agreement system and was cut ₩15 per capsule, hampering the product’s external growth. Even excluding the potential threat of reimbursement reevaluations, Godex will incur a ₩2.4 (4%) drop in annual sales from its current ₩60 billion in annual sales. Meanwhile, the PVA system was implemented with the positive-listing system to improve drug price management and encourage appropriate use of NHI finances. The PVA system discounts a drug’s price by up to 10% through negotiations between the pharmaceutical company and NHIS for products whose use volume had exceeded a certain rate. The system is largely categorized into those applied to new drugs and generic drugs, as ▲Type A (new drug); ▲Type B (new drug); ▲Type C (drugs and generics listed without negotiations). Type A applies to cases where the volume of the estimated claims exceeds the volume negotiated with the NHIS by over 30%. Type B applies to claims volume increases by ① over 60% from the previous year, or by ② over 10% and exceeds ₩5 billion for drugs in the same therapeutic class for which the maximum volume had already been adjusted according to type A. Drugs fall under Type C when claims of products in the same therapeutic class ① increase by over 60% from the volume of claims filed in the previous year, or ② has increased over 10% but the increased volume exceeds ₩5 billion and does not fall under PVA Type A or Type B. However, drugs with an annual claims volume less than ₩1.5 billion, whose ceiling price is less than the arithmetic average of other same-ingredient drugs, and Drug Shortage Prevention Program drugs are not subject to PVA.
- Company
- Poziotinib responds 100% to pts with lung cancer mutations
- by Sep 07, 2022 05:52am
- Poziotinib, a new lung cancer drug exported by Hanmi Pharmaceutical, was found to have a significant effect on the G778 mutation, which is common in patients with HER2 Exxon20 insertion mutation. As a result of ZENITH20 clinical subanalysis, 12 patients showed 100% response, and PFS was also longer than other HER2 Exxon20 mutants. In particular, when Poziotinib was first used, the PFS reached 9.8 months. ESMO pre-released a draft of clinical studies scheduled to be announced ahead of the opening of the academic conference on the 5th (local time). Further analysis results of ZENITH20 clinical trials conducted by Hanmi Pharmaceutical partner Spectrum Pharmaceuticals were also published. Poziotinib is a pan-HER2 anticancer drug that Hanmi Pharmaceutical transferred technology to the spectrum in 2015. Spectrum has taken over the right to develop and commercialize Poziotinib in countries around the world except Korea and China. At the end of last year, Spectrum filed an application for Poziotinib's permission with the U.S. Food and Drug Administration (FDA) based on the results of the cohort 2 study among the ZENITH20 Global Phase 2. The official review process will begin in February and an advisory committee will be held this month. The data released this time is the result of confirming the effect of Poziotinib in the patient group with the G778 mutation among subtypes of non-small cell lung cancer with HER2 Exxon20 insertion mutation. According to the spectrum, the G778 mutation is one of the most common submutants found in 9-19% of patients with HER2 Exxon20 insertion mutation. Of the 170 patients who participated in the ZENITH20 study, a total of 14 patients showed G778 mutations among non-small cell lung cancer patients with HER2 Exxon20 insertion mutations. They were included in cohort 2 and cohort 4, respectively. Cohort 2 is for patients with past treatment experience, and Poziotinib 16mg was administered (QD) per day. Cohort 4 administered one pill a day of Poziotinib 16mg or two tablets a day (BID) of 8mg to patients with no history of treatment. As a result of analyzing 12 people who can be evaluated out of 14, all of them (100%) showed PR, and the DoR median value was 5.5 months. The median PFS was 7.8 months. In particular, in the case of cohort 4 consisting of patients with no treatment experience, the median PFS value reached 9.8 months, which was superior to the group of patients without G778 mutation. The PFS of the patient group without G778 mutation was 5.5 months in cohort and 45.6 months in cohort. Side effect profiles were similar to existing TKI ratings. Spectrum commented, "No treatment experience or Poziotinib was effective in G778."
- Company
- Kisqali’s sales surge, Ibrance’s sales falter
- by Sep 06, 2022 05:51am
- Competition for breast cancer-treating cyclin-dependent kinases (CDK) 4/6 inhibitors in the market are heating up. Kisqali, which was the last to enter the market, has grown rapidly in the first half of this year and exceeded sales of the runner-up product in the market, Verzenio. Ibrance, the sole leader in the market, has also seen a downfall in semiannual sales for the first time this year. According to the market research institution IQVIA, the domestic market size for CDK 4/6 inhibitors in 1H this year was ₩44.5 billion, an 8.4% increase from the ₩41.1 billion of the previous year. CDK 4/6 inhibitors control cell division and growth and selectively inhibit the proliferation of cancer cells. The drugs are mainly used to treat hormone receptor (HR)-positive or human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, which accounts for 60% of all breast cancers. Since the entry of the first CDK 4/6 inhibitor, Pfizer’s Ibrance (palbociclib) 6 years ago, Lilly’s Verzenio (abemaciclib), and Novartis’s Kisqali (ribociclib) followed, totaling the number of CDK 4/6 inhibitors in the market to 3. Ibrance, which overtook the market as a 'first-in-class' drug, experienced its first decrease in sales, recording ₩28.9 billion, down 11.3% from the ₩32.6 billion of the previous year. Ibrance, which had entered the market 3 years ahead of the other two products, has been leading the CDK4/6 inhibitor market emerging as a new treatment option for breast cancer patients who had to use chemotherapy, which had many systemic side effects. Its sales also grew every year and recorded ₩40 billion in annual sales during its unrivaled 3 years in the market. Last year, the drug saw sales of ₩65.6 billion. However, with the first-ever reduction in sales shown in the first half of this year, it is highly likely that its annual sales will also fall for this year. On the other hand, Kisqali, which was the last to enter the market, has shown marked growth during the same period. Kisqali sold ₩9.7 billion in the first half of the year, a 236.6% increase from the ₩2.9 billion it had made the previous year. Such an increase in Kisqali’s sales is expected to hurt Ibrance’s sales. Kisqali’s sales had first exceeded ₩1 billion in quarterly sales in Q4 2020 when it first started receiving insurance reimbursement. Since then, its sales had risen continuously to surpass that of Verzenio for the first time in Q3 last year. This year, the drug continued to make sales far exceeding that of Verzenio, making ₩4.4. billion in Q1 and ₩5.3 billion in Q2 this year. The analysis is that the rise in Kisqali‘s sales is attributable to the fact that it is the only first-line treatment option among CDK4/6 inhibitors that can be used in premenopausal breast cancer patients. Reimbursement for the drug had been extended to premenopausal breast cancer patients who had failed ‘adjuvant chemotherapy’ since Q3 last year, further accelerating sales of the drug. Although it is the only drug among CDK4/6 inhibitors that require ECG monitoring before initiating treatment, it had improved reliability by demonstrating consistent overall survival (OS) improvement in premenopausal, perimenopausal, and postmenopausal patients. Verzenio’s sales rose 5% YoY to record ₩5.9 billion in 1H this year. Verzenio’s sales have also been steadily increasing, but at a rate slower than that of Kisqali, and has been recording quarterly sales in the ₩2 billion range for 5 consecutive quarters.
- Company
- Prevenar 13 set to make ₩40B this year
- by Nho, Byung Chul Sep 05, 2022 05:55am
- Pfizer’s Prevenar 13 was found to be maintaining its overwhelming 70% share in the pneumococcal vaccine market. According to its distribution & shipment performance data, sales of Prevenar 13 in 1H this year reached ₩19.4 billion, and its annual sales are expected to exceed that of the ₩38.1 made last year. In terms of growth, the growth of its competitor, MSD’s Prodiax 23, is slightly ahead. The product’s 1H sales were ₩8.5 billion, and if it maintains the status quo, its gross sales will exceed that of the ₩14.8 billion it had made in 2021. To strengthen its capabilities, Pfizer joined forces with Chong Kun Dang, one of the strongest players in sales & marketing at general hospitals and clinics in Korea. Since then, sales of Prevenar 13 have been slowly recovering after dipping downward due to the aftermath of the COVID-19 pandemic. Prevenar 13 had made a record performance in 2020, grossing ₩81.3 billion, a quantum leap from the ₩50 billion it had made in 2018 and 2019. The analysis is that such a rise in sales of Prevenar 13 in 2020 was due to a temporary surge in demand caused by concerns about worsening pneumonia symptoms caused by COVID-19 acute respiratory syndrome. After the supply and demand for COVID-19 vaccines and treatments, such as Paxlovid, became stabilized and the situation is nearing an endemic, sales are returning to place. In terms of maximum performance, Prevenar 13 had sold 5.5 times more products than Prodiax 23. However, in terms of market penetration, Prodiax 23 has better penetrated the market, drawing a steady upward curve in its share without ups and downs. Prodiax 23’s gross sales have drawn an upward S curve from 2018 to 2021, rising from ₩0.34 billion in 2018 to ₩0.5 billion in 2019 to ₩14.7 billion in 2020, then to ₩14.8 billion in 2021, the growth is evaluated as an encouraging phenomenon in terms of marketing growth potential. Meanwhile, Prevenar 13 prefilled syringe inj. was approved in 2010 for the “prevention of invasive pneumococcal disease caused by streptococcus pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).” Prodiax 23 and Prodiax 23 prefilled syringe, approved in 2000 and 2016 respectively, are indicated for the “prevention of pneumococcal disease caused by vaccine-containing streptococcus pneumoniae capsule,” and their efficacy in preventing pneumococcal pneumonia and bacteremia has been demonstrated in controlled clinical trials and case-control studies that were conducted in South Africa and France.
- Company
- What are the chances of Dovprela's successful benefits?
- by Eo, Yun-Ho Sep 05, 2022 05:55am
- Attention is focusing on whether the new tuberculosis drug Dovprela, which appeared in 50 years, can be listed on the insurance benefit list. According to related industries, Viatris Korea's Dovprela passed the HIRA Pharmaceutical Benefit Evaluation Committee on the 1st. Dovprela, which was approved in Korea in October last year after U.S. approval in September 2019, can be used as a combination of three types of therapy with Bedaquiline and Linezolid in adult patients with extensive drug-resistant pulmonary tuberculosis, treatment-resistant or non-reactive multidrug-resistant tuberculosis. This drug is the first new treatment in more than 50 years. The TB treatment market has been shunned by front-line pharmaceutical companies for its poor drug economy. Dovprela is a drug created through collaboration with a non-profit organization called "TB Alliance" with Viatis. Multidrug-resistant tuberculosis is resistant to two or more tuberculosis treatments, including Isoniazid and Rifampicin, which are the two most effective anti-tuberculosis drugs for tuberculosis treatment, and is not treated with the treatment. The causes of the outbreak are divided into primary resistance and acquisition resistance, which are infections with resistant tuberculosis bacteria from the beginning, and acquisition resistance is when resistance is acquired during treatment due to arbitrary discontinuation of drug use and irregular administration. Multidrug-resistant tuberculosis has a treatment success rate of only about 50%, so the treatment efficiency is low, and secondary drugs used for treatment have more side effects than primary drugs. Since the treatment period is also long, 18 to 24 months, the cost burden is high, and in some cases, lesions must be removed through surgery. The combined treatment of seven drugs, including Bdq, which are currently used in the standard treatment of multidrug-resistant tuberculosis, is not well used in Korea due to its high drug resistance rate, and the treatment period is still 9-12 months, making it difficult for patients to manage medication and the treatment failure rate high. Dovprela demonstrated its efficacy through a phase 3 clinical Nix-TB study. Dovprela is a combination of three treatments (BPaL) with Bedaquiline and Linezolid, showing a successful treatment effect of 92% in the multidrug-resistant tuberculosis group and 89% in the broad drug-resistant pulmonary tuberculosis group in six months, confirming its potential as a new short-term combination therapy. The existing treatment period of 18 to 24 months was shortened to 6 months, and within 16 weeks, almost all patients with drug-resistant pulmonary tuberculosis and multidrug-resistant tuberculosis were confirmed to have sputum culture negative. BPaL therapy is a combination of ready-to-use therapy consisting only of oral drugs, with fewer drugs than the treatment guidelines recommended to administer at least four drugs to intensive care units, and showed complete data in about 90% of patients with extensive drug-resistant tuberculosis during 6-month treatment.
