
(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
This Week In Space podcast: Episode 203 — China Rising
Step by step instructions to Deal with Your Time While Chasing after an Internet based Degree
What were the little white pills found in Tiger Woods's pocket at the scene of his crash? What to know about hydrocodone.
Is new Harry Styles music on the way? Fans think so, after a cryptic website and posters pop up.
What to know about Jack Dorsey's new Vine revival, DiVine
Exploring the Difficulties of Beginning a Family: Individual Experiences
Investigating Free Cell Phones: What You Really want to Be aware
Top Frozen yogurt Flavor: Cast Your Vote!
A definitive Manual for Choosing Indoor Plants Ideal for Your Space











