(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
Vote in favor of your Favored sort of footwear - 2Manual for Savvy Home Lighting Framework: Lights up Your Space
- 310 Hints and Deceives to Expand Cell Phone Information Use: Capitalize on Your Information
- 4‘Everybody Loves Raymond: 30th Anniversary Reunion’ premiere date: How to watch, channel, time, cast and more
- 5Choosing Moving Styles for Your Restroom Redesign
- The Most Important Crossroads in Olympic History
- Pleasant Cycle Courses All over the Planet
- Step by step instructions to Figure out the Natural Effect of 5G Pinnacles
- Find the Specialty of Calligraphy: Dominating the Exquisite Art of Penmanship
- Fundamental Home Items Each Animal person Needs
- Vote in favor of your Number one Sort of Cap
- Most loved Road Food: Which One Prevails upon You?
- The most effective method to Promoter for Cellular breakdown in the lungs Mindfulness in Your People group
- Most loved Specially prepared Espresso Mix: Which Dish Do You Cherish the Most?
