FDA posts briefing materials for advisory panel assessment of nonacog beta pegol

31 March 2017

Ahead of its Advisory Committee meeting to discuss the Biologics License Application for nonacog beta pegol, a long-acting factor IX for the treatment of hemophilia B, the US Food and Drug Administration has published briefing documents.

The meeting to evaluate the BLA submitted in May 2016 by Danish diabetes care giant Novo Nordisk (NOV: N) takes place on April 4.

The briefing documents from Novo Nordisk and the FDA, which will form the basis for the Advisory Committee's discussion, provide an overview of the non-clinical and clinical data for nonacog beta pegol for the treatment of hemophilia B.

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