(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 Pick the Best Material Organization for Your Home\ - 2The most effective method to Decisively Use Open Record Rewards
- 3Merz postpones Norway trip for Belgium talks on frozen Russian assets
- 4The Way to Business: Startup Illustrations Learned
- 5What's an atmospheric river? AP explains the weather phenomenon
- What to know about voluntary chocolate recall
- Eating ultra-processed foods could raise precancerous polyp risk for women under 50, according to research
- The Solution to Flexibility: Developing Internal Fortitude Notwithstanding Misfortune
- Moldova says Russian drones violated airspace
- James Webb Space Telescope watches 'Jekyll and Hyde' galaxy shapeshift into a cosmic monster
- Trump administration plan to reduce access to some student loans angers nurses, health care groups
- Mali and Canadian miner Barrick agree to resolve tax dispute, ending 2-year standoff
- Man who grabbed Ariana Grande at 'Wicked: For Good' premiere also rushed Katy Perry onstage this year. Who is he and why is he doing this?
- Flu concerns grow in US as UK sees more cases among kids
