(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
Dancing through the crackdown: The satirical song soundtracking post-Khamenei Iran - 2Novartis eyes more bolt-on acquisitions, CEO says
- 3Instructions to Explore the Universe of Vehicle Leases
- 4Director of Swiss hospital describes the rush to treat the injured from Alpine resort bar fire
- 55 Breakout Stars in Ongoing television Series
- 7 Methods for further developing Rest Quality
- Why are NASA's Artemis astronauts wearing orange? What are they bringing to space? What to know about the preparation for their moon mission.
- The Response to Self-improvement: Embracing a Development Outlook
- ‘Downton Abbey: The Grand Finale’ hits streaming: How to watch, cast info and everything you need to know
- Must-See Attractions in Australia
- Full SNAP benefits must be paid ‘promptly,’ USDA tells states as government reopens
- Discovery of ancient pleasure boat reveals Egypt's maritime history
- It Looks Like a Tiny, Fluffy Dragon, But It's Really a Bird. Meet the Great Eared Nightjar
- Saudi Arabia says it intercepted 7 missiles, debris falls near energy facilities
