The New York-based drugmaker is seeking to expand Hympavzi’s label to include patients aged 6 years and older with hemophilia A or B who have inhibitors. The application also covers children between the ages of 6 and 11 who do not have inhibitors. According to Pfizer, the FDA grants priority review specifically to medicines that demonstrate the potential for significant improvements in treating serious diseases.
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FDA Fast-Tracks Pfizer’s Hemophilia Drug for Pediatric Use
Pfizer announced on Friday that the U.S. Food and Drug Administration has granted priority review for an expanded application of Hympavzi, its hemophilia treatment. The regulatory move targets two high-need patient groups, including younger children, with a final decision expected in the second quarter.
Broadening the Pediatric Scope
If the agency grants a green light, Hympavzi would mark a milestone as the first nonfactor prophylactic treatment available for children aged 6 to 11 with hemophilia B. This expansion would address a critical gap in the current treatment landscape for younger patients, offering a new preventative option where few currently exist.The FDA has established a target action date for the second quarter of this year. At present, Hympavzi is only approved in the U.S. for patients 12 and older with hemophilia A or B who do not have factor VIII or factor IX inhibitors.
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