(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
Israel's fractured opposition hands Netanyahu a full term - 2A definitive Manual for Choosing Indoor Plants Ideal for Your Space
- 3NATO official says members often aren't buying weapons together, and it's a mistake
- 4The 10 Most Persuasive Forerunners in Innovation
- 5Scientists solve the mystery of the prehistoric 'Burtele Foot'
- An Extended time of Careful Nurturing: Individual Bits of knowledge on Bringing up Kids
- Vote in favor of your Favored kind of pasta
- As her kidneys fail and time runs short, this activist fights to decriminalize euthanasia in Mexico
- An Artemis 2 astronaut took a 'bath' on camera on the way to the moon. Mission Control's reaction was priceless (video)
- Investigate Something else for Less: Financial plan Travel Objections
- Carrefour becomes first European retailer to offer shopping on ChatGPT
- Horses really can smell our fear, new study finds
- Doctor's orders? ‘Belly laugh at least two to five days a week'
- Who plays Moana in the live-action remake? What to know about Catherine Lagaʻaia.
