
(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
Early Thanksgiving week forecast: Where Americans can expect cold, rain and snow for the holiday - 2
A few Up-to-date Sacks - Stylish Young ladies Shouldn't Miss - 3
Moving Wedding Objections for Paramount Functions - 4
Rights group: At least 2,500 deaths during protest crackdown in Iran - 5
Satellites capture aftermath of Ethiopian volcano's 1st eruption in recorded history (images)
How did life begin on Earth? New experiments support 'RNA world' hypothesis
Doulas play essential roles in reproductive health care – and more states are beginning to recognize it
Cruising Solo All over the Planet: An Excursion of Self-Disclosure
Dolly Parton misses Dollywood event due to 'a few health challenges' after skipping honorary Oscars
How did humans evolve, and will we evolve more?
A few Exemplary Chinese Dishes, Which Are Famous Around the world
Geminid shooting stars: One of 2025's most exciting meteor showers begins tonight
Watch China's Shenzhou 22 rescue ship arrive at Tiangong space station (video)
Top 10 Arising Advances That Will Shape What's in store













