(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
Popular Japanese Hotel Chain Now Lets You Show Up With Just Your Passport - 2Genesis Marks 10th Anniversary With Magma GT Concept Aimed at High-Performance Flagships
- 3As tetanus vaccination rates decline, doctors worry about rising case numbers
- 4Unwinding the Starting points of America: An Excursion Through History
- 5Vehicle Lovers' Decision: Purchase A Reasonable Vehicle
- Blue Origin safely launches wheelchair user to space and back
- Russia Establishing Long-Range Drone Bases In Belarus, Warns Ukraine
- Vote In favor of Your Favored Pizza Cover
- Figure out How to Explore the Infotainment Framework in the Slam 1500.
- What are the health benefits of whole milk for kids?
- Two Indonesian UN peacekeepers killed in explosion in Lebanon
- The architect of Iran’s military survival remains defiant
- One perk to marrying Richard Marx later in life? 'We don't have time' for stupid arguments, says Daisy Fuentes.
- Greece eyes migrant repatriation centres outside the EU
