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FDA clears Octapharma's NUWIQ for hemophilia A

  • The FDA approves privately-held Octapharma's NUWIQ, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children with hemophilia A. The approval includes on-demand treatment and control of bleeding episodes, routine prophylaxis to reduce the frequency of bleeding episodes and perioperative management of bleeding.
  • NUWIQ is the first B-domain-deleted recombinant Factor VIII derived from a human cell line, not chemically modified or fused with another protein, for the treatment of hemophilia A, which affects ~16K Americans.
  • NUWIQ was cleared in Europe in August 2014.
  • Related tickers: (BAX +0.3%)(BXLT -0.5%)(OTCQX:RHHBY +0.6%)(SGMO +2.4%) (OTCPK:CHGCY) (OPK +2.3%)(ALNY)(BIIB +0.5%)(OTCPK:BAYRY +0.4%)

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