(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
Significant Elements to Consider Prior to Applying for a Mastercard: 6 Vital Contemplations - 2‘The White Lotus’ sparked online interest in risky anxiety pills, study says
- 3Overlooked infertility care should be part of national health services, says WHO
- 44 Electric Vehicle Brands: Execution, Unwavering quality, and Development
- 5Flourishing as a Charitable Pioneer: Individual Encounters in Generosity
- They relied on marijuana to get through the day. But then days felt impossible without it
- Happy with Running Shoes for 2024
- Figure out How to Explore the Infotainment Framework in the Slam 1500.
- From Sea shores to Urban areas: Astonishing Worldwide Travel Objections
- The most effective method to Decide the Best Auto Crash Attorney for Your Lawful Necessities
- Cyclone causes blackout, flight chaos in Brazil's Sao Paulo
- Bavarian leader questions Germany's Eurovision participation
- Underestimated Metropolitan Experience Urban communities On the planet
- Would you ever turn to AI for companionship? 6% of Americans say they could — or already have.
