(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
Twins were the norm for our ancient primate ancestors − one baby at a time had evolutionary advantages - 2There was a bit of toilet trouble on NASA's Artemis 2 mission to the moon
- 31,000-mile Saharan dust storm, from the sky and from the ground
- 4Kendall Jenner addresses long-standing rumor about her sexuality
- 5Jamie Dimon warns Iran war could drive inflation, interest rates higher
- Instructions to Amplify Certifiable Experience While Chasing after an Internet Advertising Degree
- Upgrading the Healthy benefit of Your Local Vegetables
- Mosquitoes carrying malaria are evolving more quickly than insecticides can kill them – researchers pinpoint how
- Pick Your Favored method of transportation
- HGV driver recruited others to smuggle migrants
- Iran’s Crown Prince Reza Pahlavi backs protests: Join your fellow citizens in the streets
- 2024 Eurovision winner Nemo returns trophy over Israel's participation
- Former defense minister Gallant vacated home over security threat under Shin Bet direction
- Shredded cheese recall: Multiple brands sold at Aldi, Target and Walmart affected over potential metal fragment contamination
