Biogen Idec announced that the US Food and Drug Administration (FDA) has extended its review of a marketing application for the long-lasting recombinant factor IX Fc fusion protein Alprolix for haemophilia B by three months.
The company noted that the agency requested additional information related to the validation of a manufacturing step for the therapy.
Biogen Idec had submitted additional information regarding the validation of a manufacturing step for ALPROLIX in response to a request from the FDA.
ALPROLIX is a clotting factor under development using Biogen Idec's proprietary Fc fusion technology, which makes use of a naturally occurring pathway that delays the breakdown of IgG1 in the body and cycles it back into the bloodstream.
The Fc portion of IgG1 is fused to factor IX in ALPROLIX and is thought to be responsible for the prolonged time ALPROLIX circulates in the body.
ALPROLIX is also under review by regulatory authorities in several countries, including Canada, Australia and Japan.
Hemophilia B is a blood clotting disorder caused by a mutation of the Factor IX gene, leading to a deficiency of Factor IX. The inherited disorder is caused by having substantially reduced or no factor IX activity, which is needed for normal blood clotting.
Prophylactic infusions of factor IX can temporarily replace clotting factors necessary to control bleeding and prevent new bleeding episodes.
