(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
Artemis II astronauts will see parts of the moon no human has before. Here’s how - 2Abbott issues US device correction for some glucose monitors over faulty readings risk
- 3These are the Fastest Italian Sports Cars
- 4SpaceX's 1st 'Version 3' Super Heavy Starship booster buckles under pressure during initial tests
- 5Figure out How to Adjust Work, Life, and an Internet based Degree
- The most effective method to Comprehend the Variables Affecting Medical attendant Pay rates
- Japan deploys the military to counter a surge in bear attacks
- What we know about the 'Stranger Things' spinoff — plus the one cast member who guessed it correctly
- Several injured as man threatens attack on German high-speed train
- Former Australian soldier arrested over alleged Afghan war crimes
- A single shot of HPV vaccine may be enough to fight cervical cancer, study finds
- Belarusian parliament passes a bill to crack down on LGBTQ+ rights
- The most effective method to Apply Antiquated Ways of thinking in Current Brain science Practices
- An Extended period of Voyaging Carefully: the World with Reason
