Biogen Idec (BIIB) and Swedish Orphan Biovitrum AB recently presented new data on their hemophilia B candidate, Alprolix, at the XXIV International Society on Thrombosis and Haemostasis (:ISTH) Congress.
Data presented by Biogen and Swedish Orphan Biovitrum supported Alprolix’ safety, efficacy and pharmacokinetic profile.
According to the new data, one injection of Alprolix helped control more than 90% of bleeds while more than 97% of bleeds could be controlled by two or fewer injections. Moreover, bleeding during and after 14 major surgeries were controlled by Alprolix in 12 patients with hemophilia B.
Biogen and its partner, Swedish Orphan Biovitrum, had initially presented positive phase III top-line results on Alprolix last year. Results from the global, open-label, multi-center B-LONG study had shown that Alprolix was effective in controlling and preventing bleeding, routine prophylaxis, and perioperative management. Results showed that a single injection of Alprolix helped control 90.4% of bleeding episodes.
A pharmacokinetic analysis was also conducted. The approximate terminal half-life of Alprolix was found to be 82 hours compared to 34 hours for Pfizer’s (PFE) BeneFIX.
The candidate was also found to be well-tolerated with no inhibitors to Alprolix being detected or cases of anaphylaxis (severe allergic reaction) being reported. Patients in the study had all switched from marketed factor IX products.
Alprolix is currently under FDA review with a response expected by year end. The company’s hemophilia A candidate, Eloctate, is also under FDA review.
A convenient dosing schedule (supported by a longer duration of action and a suitable safety profile) could help Alprolix and Eloctate capture share from existing products in the hemophilia market.
Biogen currently carries a Zacks Rank #1 (Strong Buy). Avonex and Tysabri should continue contributing significantly to sales. Meanwhile, Tecfidera should help drive long-term growth. We are also encouraged by Biogen’s progress with its hemophilia candidates.
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