
(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
7 Well known Vacation spots In The US - 2
Politics at the table? Drinking the wine you brought? An etiquette expert's Thanksgiving dos and don'ts. - 3
10 Moving Design Frill for Summer 2023 - 4
BioMarin to acquire Amicus Therapeutics for $4.8 billion in rare disease bet - 5
Virtual Domains d: A Survey of \Inundation and Ongoing interaction Mechanics\ Computer game
Surge of off‑lease electric vehicles expected to drive down used EV prices
Optimal Beauty Parlor Medicines for Upgraded Wellbeing and Appearance
Become the best at Discussion: 6 Procedures for Progress
How Google, Microsoft, Walmart, and other corporate giants are preparing for an aging workforce
Bullets in Luigi Mangione’s bag convinced police that he was UnitedHealthcare CEO killing suspect
What to know about the hepatitis B shot — and why Trump officials are targeting it
Nature's Treats: 10 Organic products That Lift Prosperity
The Magnificence of Extraordinariness: Presenting Valuable Adornments and Gemstones
UK can legally stop shadow fleet tankers, ministers believe













