(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
Canada's Friendly Sunshine Coast City Is An Outdoor Playground Perfect For Hiking And Paddling - 2Dr. Vinay Prasad's memo raises concerns about COVID-19 vaccines and pediatric mortality
- 3The Craft of Do-It-Yourself Home Stylistic layout: Change Your Space
- 4Meet Beef the bulldog, who takes slow walks with his 78-year-old friend
- 5Physicists and philosophers have long struggled to understand the nature of time: Here's why
- Top 15 Supportable Design Brands Coming out on top
- What is IDF's view on pontential long-term occupation of southern Lebanon?
- 6 Financial plan 3D Printers with the Best Worth
- Indian Health Service is digging out of decades-old construction backlog for medical buildings
- Step by step instructions to Appropriately Keep up with Your Sunlight powered chargers for Most extreme Productivity
- Charli xcx recorded original songs for 'Wuthering Heights' — what to know about the new album for Margot Robbie's film
- Doritos and Cheetos dial back the bright orange in new versions without artificial ingredients
- Best Internet based Course for Learning Another Dialect: Which Stage Do You Like?
- Former defense minister Gallant vacated home over security threat under Shin Bet direction
