
(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
Building an Individual Brand: Illustrations from Forces to be reckoned with - 2
Step by step instructions to Keep up with the Life span of Your Kona SUV's Battery Duration - 3
7 Odd Apparatuses to Make Your Party Stick Out! - 4
Rick Steves' Newest Guidebook Is A Fresh Perspective On Italy Spilling The Country's Secrets - 5
'Set up an Army Radio station at President’s Residence': Source close to Katz slams Herzog
Step by step instructions to Figure out the Natural Effect of 5G Pinnacles
Virtual Route d: A Survey of \Exploring On the web Stages\ Web Administration
Protest inspired by 'Gen Z' movement draws few young people in Mexico and many government critics
Why this Tennessee special election has the 'whole world' watching
Find the Historical backdrop of Common liberties: Advancing Equity and Equity Around the world
Find the Advantages of Deep rooted Getting the hang of: Extending Information and Self-awareness
Conquering Language Boundaries: Individual Accounts of Multilingualism
Presenting Nintendo's New Pastel Satisfaction Con Tones for Switch Gamers: 3 Upscale Choices
Far-right German youth group delegates seek deportations, remigration












