(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
Higher cost, worse coverage: Affordable Care Act enrollees say expiring subsidies will hit them hard - 2Watch live as near-Earth asteroid Eros buzzes the Andromeda Galaxy on Nov. 30 (video)
- 32023's Best 10 Cell phone Advancements You Can't Miss
- 4Ukraine demands army of 800,000 under peace plan
- 5One dead, six wounded in various crime-related shootings in Israel over the weekend
- The Excursion to Monetary Proficiency: Individual budget Triumphs
- Asia's Noteworthy Destinations: A Voyager's Aide
- With more Moon missions on the horizon, avoiding crowding and collisions will be a growing challenge
- 21 Things You Ought to Never Tell Your Childless Companion
- Vote In favor of Your #1 sort of film
- 5 Food varieties to Remember for Your Eating regimen for Ideal Wellbeing
- The most effective method to Comprehend the Variables Affecting Medical attendant Pay rates
- Full SNAP benefits must be paid ‘promptly,’ USDA tells states as government reopens
- Support Your Body: A Manual for Smart dieting and Sustenance
