
(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
The Electric Bicycle Americans Can Confide in 2024 - 2
Whale stranded off Germany for days is stuck again - 3
NASA's SPHEREx telescope completes its 1st cosmic map of the entire sky and it's stunning! - 4
Medtronic has 'significant firepower' for multiple acquisitions, executives say - 5
Enormous Credit And All that You Really want To Be aware
Defence chiefs of Thailand and Cambodia to discuss ceasefire
Step by step instructions to Choose the Right Auto Crash Legal counselor for Your Case
Russia Establishing Long-Range Drone Bases In Belarus, Warns Ukraine
China's 1st reusable rocket explodes in dramatic fireball during landing after reaching orbit on debut flight
James Webb Space telescope spots 'big red dot' in the ancient universe: A ravenous supermassive black hole named 'BiRD'
Vote In favor of Your Favored Keeping an eye on
NI economy losing momentum due to Iran crisis
The 10 Most Noteworthy Games in History
U.S. overhauls childhood vaccine schedule, recommends fewer shots













