
(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
How to watch ‘The Traitors’ Season 4: Premiere date, episode release time, full cast list and more - 2
Peruvian ex-President Martin Vizcarra sentenced to 14 years in prison - 3
It May Take a Year to Restore Abu Dhabi Aluminum Output, EGA Says - 4
'An incredible privilege and responsibility': Artemis 2's Christina Koch is ready to become the 1st woman to fly around the moon - 5
Warming winters lead to more nitrate pollution in the drinking water near farms
Gauging the Upsides and downsides of Visas: A Complete Aide
Lightning on Jupiter could be up to 1 million times stronger than on Earth
Supercharge Your Remote Work Arrangement with These Game-Changing Instruments
Netflix's 'Lord of the Flies' show blends 'Adolescence' and 'Yellowjackets'
What to know about new CDC deputy director who has been critical of COVID vaccines
25 of the world’s best sandwiches
Antimatter took to the road for the very first time. Here’s why it matters
As cases of a rare, deadly infection rise, doctors worry fewer teens will get vaccinated
‘More should be done’: UN pushes Syrian regime on justice for Druze, Alawites and minority groups












