FDA Green Lights Pfizer's Gene Therapy For Rare Bleeding Disorder Hemophilia [Yahoo! Finance]
Pfizer, Inc. (PFE)
Last pfizer, inc. earnings: 4/28 06:45 am
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Source: Yahoo! Finance
currently use factor IX (FIX) prophylaxis therapy or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var capsid Beqvez is a one-time treatment designed to enable hemophilia B patients to produce FIX themselves rather than the current standard of care, which requires regular intravenous infusions of FIX that are often administered multiple times a week or multiple times a month. Hemophilia B is a rare genetic bleeding disorder that prevents normal blood clotting because of a deficiency in FIX that causes those with the disease to bleed more frequently and longer than others. The approval is based on the BENEGENE-2 Phase 3A study, which showed that a single dose of Pfizer's therapy helped eliminate bleeding in 60% of patients?? compared to 29% in the prophylaxis arm. A median annualized bleeding rate (ABR) of zero (range of 0 to 19) was
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