Bayer's Kovaltry cleared in Europe for hemophilia

• As expected, the European Commission approves Bayer's (OTCPK:BAYRY) unmodified full-length recombinant factor VIII product, Kovaltry, for patients of all ages with hemophilia A. Clinical studies showed patients receiving Kovaltry two - three times per week were able to control bleeds and experienced protection from bleeds. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in January recommending approval.
• The company is pursuing regulatory clearance in major markets worldwide.
• Previously: European Ad Comm back Bayer's BAY 81-8973 for hemophilia A (Jan. 4)