
(Reuters) -The U.S. Food and Drug Administration is probing the death of a patient who developed harmful antibodies after taking Takeda Pharmaceuticals' blood disorder therapy, the health regulator said on Friday.
The pediatric patient died about 10 months after starting Takeda's drug Adzynma as a preventive therapy, the agency said.
The child had congenital thrombotic thrombocytopenic purpura (cTTP), an inherited condition that causes blood clots in small vessels and can lead to organ damage.
The FDA said the child developed antibodies that blocked the activity of ADAMTS13, an enzyme critical for blood clotting.
Takeda did not immediately respond to Reuters request for comment.
Adzynma, approved in 2023 as the first therapy for cTTP, replaces the ADAMTS13 protein to help prevent dangerous blood clots.
The agency added it has received multiple postmarketing reports of patients developing neutralizing antibodies to ADAMTS13 after treatment with Adzynma.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Vijay Kishore)
Kiefer Sutherland arrested after allegedly assaulting a ride-share driver in L.A.
Turkey’s intel chief lays out country’s vision for Middle East, world
This Week In Space podcast: Episode 203 — China Rising
IDF destroys two-kilometer-long Gaza terror tunnel in Beit Lahiya
Dancing through the crackdown: The satirical song soundtracking post-Khamenei Iran
Two UN peacekeepers killed in explosion in Lebanon
Whale stranded off Germany for days found stuck again
Vote in favor of Your #1 4K television: Lucidity and Drenching Matter
Shipping: The Corridors of Trade and the Coming of Another Period













