(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
Carnival fever hits Lagos as locals celebrate Afro-Brazilian heritage - 2African Forests Have Become a Source of Carbon Emissions
- 3Figure out how to Put resources into Lab Precious stones: A Novice's Aide
- 4'Heated Rivalry' is just the tip of the iceberg. How hockey became the sexiest sport
- 5World leaders, rights groups react to COP30 climate deal
- 1,000-mile Saharan dust storm, from the sky and from the ground
- Aurora chaser catches a fox basking in the glow of Finland's legendary 'fox fires' (photos)
- A Republican elected governor in California? It's not as far-fetched as it sounds.
- A Couple of Reasonable Guitars for 2024
- Landslides triggered by heavy rainfall kill at least 20 people in Tanzania
- Step in Style: A Survey of \Solace and Execution on the Track\ Running Shoes
- Bombardier Global 8000 Enters Service
- Nature: 10 High priority Setting up camp Spots In Europe
- College students are now slightly less likely to experience severe depression, research shows – but the mental health crisis is far from over
