(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
Procter & Gamble changes Crest toothpaste packaging to address Texas AG fluoride concerns - 2Remote Work Survival manual: Helping Efficiency at Home
- 3BHP liable for 2015 Brazil mine disaster: UK court
- 4Tributes pour in for MIT professor Nuno Loureiro amid unresolved shooting case
- 5The Response to Independence from the rat race: Methodologies for Creating Financial momentum
- Ukrainian Army Converts E38 BMW 7-Series Into Multiple Rocket Launch Platform
- Tzrifin base exhibition reveals Hamas and Hezbollah arms, showing structure behind attacks
- Toyota Motor Europe to roll out smart EV charging through new partnerships
- From Lounge chair to Money: Online Positions That Will Change Your Profession
- This ‘CSI: Miami’ star spent years solving crimes on TV. Then she became the target of one herself.
- 'Women on the floor, riddled with bullets': Ex-hostage Rom Braslavski recounts 'horrors' of Oct. 7
- McDonald's is bringing two 'KPop Demon Hunters' meals to McDonald's. Here's what they include and when they launch.
- Parents who delay baby's first vaccines also likely to skip measles shots
- Famous Network programs in Europe and America
