FDA Considers Risks Of Andexxa To Outweigh Its Benefits Based On Available Data

Dec 19 (Reuters) - FDA:

• FDA: ON DEC 18, SAID IT GOT POSTMARKETING SAFETY DATA ON THROMBOEMBOLIC EVENTS, INCLUDING SERIOUS & FATAL OUTCOMES, IN PATIENTS TREATED WITH ANDEXXA

• FDA: BASED ON AVAILABLE DATA, FDA CONSIDERS RISKS OF ANDEXXA TO OUTWEIGH ITS BENEFITS - WEBSITE

• FDA: ASTRAZENECA SUBMITTED REQUEST TO VOLUNTARILY WITHDRAW BLA FOR ANDEXXA FOR COMMERCIAL REASONS

• FDA: ASTRAZENECA CONFIRMED IT WILL END U.S. COMMERCIAL SALES OF ANDEXXA BY DEC 22, 2025

• FDA: ANDEXXA WILL NO LONGER BE MANUFACTURED FOR OR SOLD IN U.S. BY ASTRAZENECA AFTER DEC 22, 2025

• FDA: DEATH RELATED TO THROMBOTIC EVENTS THROUGH 30 DAYS OCCURRED IN 6 PATIENTS IN ANDEXXA ARM VERSUS 2 PATIENTS IN USUAL CARE CONTROL ARM