FDA approves Biogen Idea's Eloctate for Hemophilia A
- FDA has approved Eloctate Antihemophilic FactoVIII (recombinant) Fc fusion protein for the treatment of hemophilia A.
- Eloctate is the first antihemophilic factor fc fusion protein for the treatment of hemophilia A.
- The treatment, an injectable, helps control and prevent bleeding episodes and is designed to require less frequent dosing.
Eloctate, formulated to be longer-lasting than current typical treatments, is a designated orphan drug that was largely approved based on a clinical trial consisting of 164 subjects. Hemophilia A affects roughly one in 5,000 males born in the U.S. Eloctate is approved for children and adults.
The hemophilia B counterpart of Eloctate is Alprolix (recombinant factor IX) fc fusion protein, which was developed by Biogen Idec and received FDA approval in March. These new treatment options for patients with hemophilia are a major boon for adults and children, whose parents often find the treatment regimen difficult.
In a post-hoc analysis of the phase II clinical data on Alprolix and Eloctate, patients reported that previously they had an average of three treatments per week. However, using Eloctate, 98.9% of patients reported using fewer injections as part of their prophylactic regimen. In fact, 30% of respondents only needed an injection every five days, while 28.8% received them twice weekly. Moreover, during the last three months of treatment with Elocate in the study, patients had a median annualized bleeding rate of zero, compared with a median of six bleeding episodes in the past year on the standard-of-care regimen. The results were good overall in terms of efficacy and tolerability.