(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)
Like 'accelerating from stationary to supersonic flight': Europe's Hera probe boosts speed, stays on course for November asteroid rendezvous- Israel reports killing another senior Iranian oil official
- The Eastern Bongo, Kenya’s Rare Forest Antelope on the Brink
- The Most Vital Crossroads in Olympic History
- Find the Lively Food Markets of South America
- The most effective method to Connect Successfully with Teachers in a Web based Setting
- Journalist reported killed in the Gaza Strip
- Scientists dove hundreds of feet into the ocean and found creatures no human has ever seen. Our trash beat us there
- Geminid meteor shower 2025 peaks next week. Here's what you need to know about this year's best meteor shower
