(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
5 Morning Schedules That Stimulate Your Day - 2Find the Standards of Powerful Cooperation: Accomplishing Cooperative energy and Coordinated effort
- 3Excursion to Different Universes: the Top Sci-fi Motion pictures Ever
- 46 Famous Cell phone Brands All over The Planet
- 5Support Your Wellness: 20-Minute Home Exercises That Work
- Web designers for Independent ventures
- Regeneron's experimental therapy combo effective in untreated cancer patients
- Vietnam rethinks its flood strategy as climate change drives storms and devastation
- Merz postpones Norway trip for Belgium talks on frozen Russian assets
- Travels to Dream Objections in Europe
- A decade after Brazil’s deadly dam collapse, Indigenous peoples demand justice on the eve of COP30
- Solar storms can trigger auroras on Earth. This star’s explosion could destroy a planet’s atmosphere
- From Novice to Master: Dominating a Side interest
- Journey through Pages: A Survey of \Plunging into Scholarly Universes\
