Phase 3 data from Biogen Idec and Swedish Orphan Biovitrum AB for ELOCTATE™, the companies’ investigational recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A, were published online in the journal Blood. ELOCTATE™ uses a technology called Fc fusion to prolong the time the therapy circulates in the body, which may extend the time between prophylactic infusions.
The data were drawn from the global A-LONG study, which compared the efficacy, safety and pharmacokinetic activity of prophylactic rFVIIIFc for hemophilia A to currently available treatments. The study included 165 male patients with severe hemophilia A ages 12 years and older at 60 hemophilia treatment centers in 19 countries. ELOCTATE™ was given once or twice weekly, compared to the typical thrice weekly or every other day dosing.
According to a November 13th Biogen press release, the results from A-LONG demonstrated that “people with severe hemophilia A may achieve effective prevention or reduction of bleeding episodes with one or two prophylactic infusions a week.”
Despite the drug’s advancement, Biogen may need to push back the date for bringing ELOCTATE™ to market. The company originally anticipated rolling the drug out in the first half of 2014. According to Tony Kingsley, head of commercial operations at Biogen, the delay, which could take 90 days, would be in response to a request for additional information by the US Food and Drug Administration (FDA) about the way the manufacturing data are collected and reported.
“The FDA requested additional information related to certain steps in the validation process in our manufacturing,” said Kingsley. “We are working with them to provide that information.”
Source: Bloomberg.com, November 12, 2013