01:44 PM EDT, 10/11/2024 (MT Newswires) -- Pfizer ( PFE ) said Friday that the US Food and Drug Administration approved Hympavzi to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B without certain inhibitors.
The drug is approved for adults and pediatric patients 12 years or older, according to the company.
The approval is based on results from the phase 3 trial, which showed the drug reduced the annualized bleeding rate by 35% and 92% after a 12-month active treatment, respectively in patients with hemophilia A, without factor VIII inhibitors, or hemophilia B, without factor IX inhibitors.
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