
(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
Step by step instructions to Keep up with Great Hand Cleanliness Before Handshakes - 2
Artemis II's moon-bound astronauts capture Earth's brilliant blue beauty as they leave it behind - 3
6 Famous kind of practice on the planet - 4
Make your choice for the music application with the most amicable connection point! - 5
Israel has clear objectives south of Litani River, but will face difficult choices further north
Discovery off Israel’s coast reveals earliest known 2,600-year-old shipment of raw iron
A Colombian city swaps iconic horse buggies for electric carriages amid animal welfare concerns
In vogue Sleepwear Patterns for 2024
FDA proposes use of sunscreen ingredient popular in other countries
Bad flu season getting worse; skyrocketing cases set state record
Polish law aimed at lowering petrol prices takes effect
5 Different ways Macintosh is Prepared to Overwhelm Gaming, Even Against Windows
Qantas and Virgin Australia Ban Power Bank Usage on Flights Following Safety Incidents
South America's Memorable Destinations: A Movement Guide













