
(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
Must-Sit in front of the Programs from Europe and the US - 2
The Incomparable Advanced cameras: Which One Will Win? - 3
Family Matters: Tips and Guidance for Effective Nurturing and Everyday Life - 4
Step by step instructions to Guarantee Your Lab Precious stone is Morally Obtained - 5
Smooth out Your Funds: Cash The board Simplified
Vote in favor of Your #1 Instructive Toy: Learning and Tomfoolery Joined
Find the Advantages of Positive Nurturing: Supporting Cheerful and Sound Kids
7 Powerful Techniques to Boost Efficiency with Your Cell Phone: A Far reaching Guide
More charges filed against ex-left-wing RAF member Daniela Klette
My daughter is in the #1 movie in the country. She still has to finish her math homework.
7 Extraordinary Efficiency Applications for Experts
Congolese rape survivors search in vain for medicine after USAID cuts
Scientists find new clues to why female fertility declines with age
EU waters down plans to end new petrol and diesel car sales by 2035













