Bayer Helixate Promotions Contain Unsupported Safety, Efficacy Claims, CBER Letter Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Promotional materials for factor VIII antihemophilic could be interpreted to mean that no other hemophilia A therapy offers better viral safety than Helixate FS, FDA says. The agency also objects to claim that the biologic provides greater efficacy due to its 2.5 mL size.