(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)
LATEST POSTS
- 1
US healthcare spending soars to over $5 trillion in 2024 - 2Instructions to Redo Your Kona SUV for Improved Tasteful Allure and Usefulness
- 3Shah Capital pushes for Novavax sale, warns of proxy fight
- 4A definitive Manual for Well known Fragrances
- 5Brexit's Effect on New York's Ascent as a Main Monetary Center
- A new mom skipped a routine appointment. An infected cut led to a devastating diagnosis
- Figure out how to Use Your Brain research Degree in the Gig Market
- Last Christmas, 3 million viewers watched a Chiefs love story — will Bills fans fall just as hard this year?
- Italy Brings In New Measures In 2026 To Tackle Overtourism
- A Manual for SUVs with Less Noteworthy Gas Mileage
- European nations criticise Israel’s death penalty plans
- Want to make America healthy again? Stop fueling climate change
- German Cabinet advances bill to cut greenhouse emissions from fuels
- 6 Pet Sitting Administrations for Your Cherished Pets
