CHMP positive for BAY 94-9027 for treatment and prophylaxis of bleeding in patients with haemophilia A.- Bayer.

Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended BAY94-9027 for the marketing authorization for treatment and prophylaxis of bleeding in previously treated patients 12 years of age or older with hemophilia A. The CHMP recommendation is based on results from the Phase II/III PROTECT VIII trial. BAY94-9027 recently received FDA approval in the U.S. where it is marketed under the brand name Jivi.

Comment: BAY94-9027 was engineered to have an extended half-life by harnessing proven PEG-technology, which could extend the blood�s ability to coagulate for longer.The current standard treatment for severe hemophilia A is regularly scheduled prophylactic infusion of factor VIII to keep levels high enough to prevent bleeding. Due to the short half-life of currently marketed factor VIII products, prophylaxis may require treatment as often as every other day. Bayer�s compound is engineered to extend the circulating half-life while preserving full biologic activity through site-specific pegylation. This site-specific pegylation is achieved by inserting a single cysteine (amino acid) on the factor VIII surface, which serves as an attachment site for a polyethylene glycol (PEG) polymer.