Keywords: Bayer, BAY79-4980 recombinant Factor VIII, Research,

Bayer says Ph II BAY79-4980 recombinant Factor VIII trial will not meet primary endpoint

Article | 25 January 2010

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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