Novo Nordisk's Alhemo approved in Korea

Can be used regardless of factor VIII or IX inhibitor status

Once-daily subcutaneous prophylaxis broadens treatment options

 

Novo Nordisk’s ‘Alhemo’

Novo Nordisk Korea announced that the Ministry of Food and Drug Safety (MFDS) has approved Alhemo (concizumab) for routine prophylaxis to prevent bleeding episodes in patients aged 12 years and older with hemophilia.

Alhemo can be used in patients with both hemophilia A and B, regardless of the presence of factor VIII (FVIII) or factor IX (FIX) inhibitors.

Notably, it is the first once-daily subcutaneous prophylactic therapy available for patients with hemophilia B who have developed factor IX inhibitors, a population that previously had limited treatment options.

Concizumab, the active ingredient in Alhemo, prevents bleeding by blocking tissue factor pathway inhibitor (TFPI), thereby increasing thrombin generation.

Its Korean approval was based on results from the global Phase III explorer7 and explorer8 clinical trials.

The explorer7 study evaluated prophylactic efficacy in patients with hemophilia A or B who had developed factor VIII or IX inhibitors. Results showed that patients receiving Alhemo prophylaxis had an annualized bleeding rate (ABR) of 1.7 for treated spontaneous and traumatic bleeding episodes, representing an approximately 86% reduction compared with 11.8 in the non-prophylaxis control group.

In addition, 63.6% of patients receiving prophylaxis achieved zero bleeding, experiencing no bleeding episodes requiring treatment over a 24-week period. The median annualized treated bleeding rate was zero.

Long-term follow-up demonstrated that plasma concizumab concentrations remained stable, and no new thromboembolic events were reported through 56 weeks after the clinical trials resumed. Alhemo is administered using Novo Nordisk's prefilled pen device, designed with patient convenience in mind. The device also allows individualized maintenance dose adjustments based on the patient's body weight and plasma concentration.

Kasper Roseeuw Poulsen, General Manager of Novo Nordisk Korea, said, "Alhemo offers a new prophylactic treatment option for patients with hemophilia B and factor IX inhibitors, an area where treatment options have been limited. We expect its convenience in administration and bleeding prevention effect to improve the patients’ treatment experience.”