(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
A definitive Manual for Picking Electric Vehicle: Decision in favor of Your Number one - 2Opening Monetary Information: Your Exhaustive Manual for Finding out about Individual budget
- 3Judge sets $60K bond for Florida congresswoman accused of stealing $5M in COVID-19 funds
- 4Israel explores creation of int'l force with Greece, Cyprus to deter Turkey
- 5SF Chinatown's historic Empress of China building being revived into cultural campus
- 9 Under-The-Radar Malaysian Islands To Consider Instead Of Thailand Or Indonesia
- Step by step instructions to Pick A Keep money with High Fixed Store Loan costs
- Guinea-Bissau's coup called a 'sham' by West African political figures
- Discovering a true sense of harmony: Contemplation and Care Practices
- Top 20 Wellbeing and Wellness Applications for a Sound Way of life
- Doggie diversity in size and shape began at least 11,000 years ago
- US healthcare spending soars to over $5 trillion in 2024
- Fundamental Home Items Each Animal person Needs
- A whale stranded at a Baltic Sea resort has swum off a sandbank. But it isn't safe yet
