(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
KJ Apa stars as Jimmy Stewart in new biopic: See his transformation - 2Everything to know about NASA's moon mission launching this week
- 3Three arrested in Paris after attempted bomb attack outside Bank of America
- 4Syria rejects forced deportations from Germany amid migration debate
- 56 Modest and Strong Tire Brands
- Miley Cyrus details her fear of paper, says fiancé Maxx Morando opens their packages outside: 'That's really why I got engaged'
- NASA’s history-making moon mission aims to send the first woman and person of color to deep space
- 7 Fast Approaches to Let loose Space on Your Telephone in a flash
- Heavy rain, floods kill at least 45 people in Afghanistan, Pakistan
- Step by step instructions to Boost the Eco-friendliness of Your Smash 1500.
- An Extended time of Self-Reflection: Self-awareness through Journaling
- Thyssenkrupp to suspend electrical steel production at French site
- Brilliant and Gleaming: Excellence and Skincare Practices
- Al-Sharaa denies he called for 80% of Syrians to return from Germany
