(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 Most Enrapturing Authentic Milestones to Visit - 2Pope Leo XIV calls for urgent climate action and says God’s creation is 'crying out'
- 3Israel strikes Iranian nuclear development facilities, Tehran vows retaliation
- 4Ever Wonder What An EV Motorcycle Water Crossing Would Be Like? Here You Go
- 5What is the Significant Tech Expertise to Master Today?
- Europe must reinvent warfare for ‘era of shocks,’ NATO’s Vandier says
- Must-See Attractions in Australia
- Car Investigation: A Survey of \Past the Outside\ Car
- The most effective method to Pick the Right Material Organization: Fundamental Tips
- Discovery of massive spider's web in Greece reveals unexpected behavior
- IDF Givati Brigade soldier arrested, charged in suspected Iran espionage
- January’s full wolf supermoon and the Quadrantid meteor shower will start off the new year
- Gov’t approves millions for border cities in North under Hezbollah fire
- Picking the Right Home Machines: A Commonsense Aide
