
(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
Trump announces 'Patriot Games' with 2 competitors from every state and territory: What we know - 2
The Craft of Do-It-Yourself Home Stylistic layout: Change Your Space - 3
Top Music and Dance Celebration: Which One Gets You Going? - 4
Most loved Caf\u00e9 Chain: Where Do You Get Your Caffeine Fix - 5
Flu cases spiking this holiday season, CDC data shows
Seven deaths possibly linked to malfunctioning glucose monitors
Why the weirdest sea level changes on Earth are happening off the coast of Japan
Texas cities have some of the highest preterm birth rates in the US, highlighting maternal health crisis nationwide
This Week In Space podcast: Episode 189 — Privatizing Orbit
The Golden Globes is happening Sunday: Who's nominated, who's hosting and how to watch
10 Hints and Deceives to Expand Cell Phone Information Use: Capitalize on Your Information
Vote in favor of your Number one Kind of Shades
Top 10 Arising Advances That Will Shape What's in store
Figure out How to Get a good deal on Your Rooftop Substitution Venture












