(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
The Best 15 Applications for Efficiency and Association - 2Figure out how to Separate Among Fledgling and Master Fender bender Legal counselors
- 3Early diagnosis leads King Charles to scale back cancer treatment in the new year
- 4Several Israelis attempt to cross into Gaza, escorted back to Israel by IDF
- 5Fundamental Home Machines: An Easy to understand Determination Guide
- This cafe takes orders in sign language. It's cherished by the Deaf community
- 25 Years Ago, Audi's Rosemeyer Concept Was A Steampunk Supercar With A Massive Engine
- South Carolina's measles outbreak reaches 434 cases
- Careful Nurturing: Techniques for Bringing up Tough Children
- New Jordan security fence could be done in early 2028
- Interstellar comet 3I/ATLAS' journey through our solar system, in photos
- SpaceX launches Starlink satellites on its 150th Falcon 9 mission of the year
- Real time features for Films and Programs
- The Way to Monetary Health: Individual budget Change
