
(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
Rescuers again fail to free whale stranded on Germany's Baltic coast - 2
Flu cases spiking this holiday season, CDC data shows - 3
AI is providing emotional support for employees – but is it a valuable tool or privacy threat? - 4
Poland identifies two Ukrainian suspects in railway sabotage blast - 5
Instructions to Perform Fundamental Upkeep on Your Slam 1500.
Moscow: Russia well-positioned to withstand oil market shocks
Monetary Wellness: Planning Tips for Independence from the rat race
I'm a woman who's into weightlifting. Was I man enough for the creatine-packed 'Man Cereal'?
Investigating Remarkable Espresso Flavors: Upgrade Your Day to day Blend
Top notch Feasting: A Manual for Worldwide Acclaimed Eateries
My prescription costs what?! Pharmacists offer tips that could reduce your out-of-pocket drug costs
5 Breakout Stars in Ongoing television Series
Former biotech CEO sued over COVID vaccine alleged insider trading
Favored Organic product for Seniors' Prosperity: Make Your Determination













