(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
Figure out How to Assess the Unwavering quality of SUVs for Seniors - 2Step by step instructions to Protect Your Speculations with Cd Rates
- 3One perk to marrying Richard Marx later in life? 'We don't have time' for stupid arguments, says Daisy Fuentes.
- 4Immortal Style: Closet Staples for Each Age
- 5From Sea shores to Urban areas: Astonishing Worldwide Travel Objections
- Iran war triggering Easter staycation boom
- UK clothing inflation climbs as Middle East turmoil threatens wider price rises
- Pilot captures jaw-dropping northern lights show from 36,000 feet (photos)
- This cafe takes orders in sign language. It's cherished by the Deaf community
- The Electric Toyota Hilux Is Finally here, But It's Not Cheap
- FBI arrests Brian Cole Jr. in Jan. 6 pipe bomb investigation, ending 5-year hunt
- Turning into a Distributed Writer: My Composing Process
- The 15 Most Compelling Books in History
- The most effective method to Guarantee Scholastic Honesty in Web-based Degrees
