Biogen Idec will have to wait a little longer before it can get the FDA’s verdict on its new haemophilia B therapy Alprolix.
The US regulator has extended its review period by three months for the long-lasting recombinant factor IX Fc fusion protein candidate, which is one of two haemophilia products licensed by Biogen Idec from Swedish Orphan Biovitrum (Sobi).
Biogen Idec said it has already provided the FDA with additional information related to the validation of a manufacturing step for Alprolix, and the agency will use the additional time to review this data.
With Alprolix for haemophilia B and its long-acting Factor VIII candidate Eloctate for haemophilia A – which was filed for approval in the US in January – Biogen Idec is hoping to challenge a market shared largely between Baxter, Pfizer and Bayer.
Both Eloctate and Alprolix make use of Fc fusion technology, which extends the half-life of the drug in the body and allows treatments to be dosed less frequently than current therapies. Biogen Idec is the first company to use this technology in heamophilia.
The established players in haemophilia are also developing long-acting variants of their products, but Biogen Idec is around a year in front and could make rapid inroads into the market.
At the moment the leading haemophilia A treatment is Baxter’s Advate, with Pfizer’s BeneFix leading the haemophilia B category, but the market looks set to get increasingly crowded.
Baxter launched an assault on the haemophilia B sector with the approval of Rixubis in the US in June, while Novo Nordisk and CSL Behring also have long-acting drugs in phase III testing.
Analysts have suggested Biogen Idec‘s haemophilia franchise could reach $1bn a year fairly quickly, even though it only has rights to the drugs in North America at the moment, with Sobi retaining ownership in Europe.
Alprolix is also under review by regulatory authorities in a number of countries, including Canada, Australia and Japan.
This article was correct on December 9, 2013, to clarify that Fc fusion technology did not belong to Sobi.