(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
New research reveals urban raccoons across the US show early signs of domestication - 2RFK Jr. says he's following 'gold standard' science. Here's what to know
- 3What to know about MIT professor Nuno Loureiro and the investigation into his shooting
- 4All that You Really want to Be aware of Dental Inserts Facilities
- 5Focus on Yourself: Wellbeing and Taking care of oneself Practices
- I work with companies to confront addiction in the workplace. The hidden crisis is costing corporate America millions.
- Tech Patterns: Contraptions That Will Shape What's in store
- Best Veggie lover Dinner: What's Your Plant-Based Pick?
- 5 Home EV Chargers for Proficient and Solid Charging
- Find Successful Magnificence Items for Sparkling Skin
- German Cabinet advances bill to cut greenhouse emissions from fuels
- Top 15 Supportable Design Brands Coming out on top
- Fundamental Archives for Beginning Your Business
- Journey Lines for Each Explorer: Track down Your Ideal Journey
