Pfizer wins FDA priority review for Hympavzi label expansion

 Pfizer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Hympavzi hemophilia drug for two patient populations with significant medical need.

Pfizer on Friday said the application covers Hympavzi for the treatment of hemophilia A or B patients 6 years and older with inhibitors, and for patients ages 6 to 11 with hemophilia A or B without inhibitors.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

New York drugmaker Pfizer said the agency has set a target action date in the second quarter for its application.

Pfizer said a green light would make Hympavzi the first nonfactor prophylactic treatment available for children ages 6 to 11 with hemophilia B.

Hympavzi is currently approved in the U.S. for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors.

https://www.morningstar.com/news/dow-jones/202602064627/pfizer-gets-fda-priority-review-for-expanded-hympavzi-approval