Isturisa, first and only Cushing's syndrome drug, prescribed

Can be prescribed at general hospitals

Has passed the drug committees (DC) of medical institutes, including Severance Hospital·Ajou University Hospital

Reimbursement listed in December…provides benefit of regulating cortisol levels

The new treatment for Cushing's syndrome 'Isturisa' is becoming available for prescription at general hospitals.  

According to industry sources, Isturisa (osilodrostat), Recordati Korea's treatment for adult Cushing’s disease, has passed the Drug Committees (DC) reviews at several medical institutions, including Sinchon Severance Hospital, Ajou University Hospital, and Chonnam National University Hwasun Hospital.

Additionally, the landing process is underway at other major tertiary hospitals, such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Asan Medical Center.

Following its inclusion on the insurance reimbursement list last December, the drug appears to be gradually expanding its prescription areas.

Cushing's disease is a rare and chronic hormonal disorder caused by a benign pituitary tumor that secretes excessive amounts of adrenocorticotropic hormone (ACTH).

If a patient is exposed to high cortisol levels over a long period due to excessive ACTH secretion, morbidity and mortality increase, and various systemic symptoms such as cardiovascular and metabolic diseases, psychiatric disorders, fractures, and osteoporosis occur.

The main treatment goals for patients with Cushing's disease are the rapid and sustained normalization of cortisol levels to improve physical signs and comorbidities and to enhance the patient's quality of life.

However, about one in three patients with Cushing's disease experiences recurrence or is not fully cured even after pituitary surgery, necessitating additional treatment. For these patients with persistent or recurrent Cushing's disease, drug therapy to lower cortisol levels is recommended, and Isturisa is currently the only drug approved in Korea for the treatment of Cushing's disease.

Isturisa demonstrated efficacy through the LINC3 and LINC4 Phase 3 studies, which involved patients with persistent or recurrent Cushing's disease who had previously relapsed after pituitary surgery or radiation therapy, or for whom surgery was not possible.

As a result of the research, in the LINC3 study, 86% of patients who continued Isturisa administration at week 34 achieved a complete response (CR) with mUFC levels below the ULN. In comparison, only 29% of patients who switched to placebo after 24 weeks of Isturisa administration achieved a CR.

In the LINC4 study, 77% of the Isturisa group and 8% of the placebo group achieved CR at week 12. Furthermore, in the LINC3 extension study, 81% of patients who were administered Isturisa up to week 72, and in the LINC4 extension study, 72.4% of patients who were administered Isturisa up to weeks 72 to 96, consistently achieved CR.

A Recordati official stated, 'Recordati is actively promoting the landing of Isturisa in major medical institutions so that Korean Cushing's disease patients, who have struggled to regulate their cortisol levels within the normal range, can receive the treatment benefits of Isturisa quickly, as it is the only drug approved in Korea for the treatment of Cushing's disease.'