Bayer says Ph II BAY79-4980 recombinant Factor VIII trial will not meet primary endpoint
German drug major Bayer Schering Pharma AG, Germany has announced that an independent Data Safety and Monitoring Board has completed an interim analysis of a Phase II trial (the LIPLONG study) of the company's long-acting recombinant factor VIII, BAY79-4980. The DSMB concluded that the study will not be able to achieve the predetermined efficacy endpoint (non-inferiority). No safety concerns were raised. As a result of the DSMB findings and recommendation, Bayer has decided to discontinue the study.
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