Bayer's Kovaltry approved in haemophilia A in US
The US Food and Drug Administration has approved Bayer's Kovaltry (antihaemophilic factor VIII) for haemophilia A in children and adults.
Bayer said yesterday that the approval of the unmodified, full-length recombinant factor VIII product, is based on results from the LEOPOLD clinical trials.
These demonstrated that Kovaltry controls bleeds and reduces frequency of bleeding episodes with routine prophylaxis in children and adults with haemophilia A when used two or three times a week.
Kovaltry has also been approved in the EU and Canada, and Bayer is pursuing regulatory filings in other markets.
Bayer's Kogenate (octocog alfa) is already approved in haemophilia A in more than 70 countries.
Bayer also has a long-acting recombinant factor VIII pipeline candidate, and is pursuing alternative clinical approaches in early clinical and preclinical development, such as gene therapy and inhibition of tissue factor pathway inhibitor, in haemophilia and other blood disorders.
Related story:
