(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
6 Popular Men's Aromas On the planet - 2Holocaust survivor, descendants urge High Court to allow Gaza children medical access
- 3Jason Kelce opens about wife Kylie Kelce's past pregnancy loss
- 4Netanyahu leads meeting on West Bank riots, Katz defends axing administrative detention for Jews
- 5Why are malnutrition deaths soaring in America?
- Syria rejects forced deportations from Germany amid migration debate
- 12 times rockets and spacecraft crashed and burned in 2025
- Exclusive-Drugmakers raise US prices on 350 medicines despite pressure from Trump
- Israel's fractured opposition hands Netanyahu a full term
- Cyprus: War-related tourism concerns and climate change efforts
- Palestinians protest against Israel's new death penalty law
- Woman, 60, Is Finally Traveling the World Decades After Husband’s Death Held Her Back
- What’s the shadowy organisation taking Gaza Palestinians to South Africa?
- Fundamental Archives for Beginning Your Business
