(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
Key Training: Picking a Significant for Monetary Achievement - 2Allow Innovative Progressions To have a Massive Effect
- 3Dependable Savvy Locks to Update Your Home Security
- 4More than 800 flights canceled as FAA cuts traffic at 40 major airports. Here's what to know.
- 5No more attempts to free whale stranded off Germany, officials say
- One perk to marrying Richard Marx later in life? 'We don't have time' for stupid arguments, says Daisy Fuentes.
- A definitive Handbook for Securities exchange Money management
- From ‘Project Hail Mary’ to Artemis II, spaceflight captures audiences when it centers on people because human space travel is hazardous
- 5 Side interests That Work on Psychological wellness
- The Minimized Passage Horse: Reconsidering a Symbol for the Cutting edge Period
- Somalia set for 'historic' first offshore oil drilling
- 7 Powerful Methods for forestalling Telephone Overheating: Keep Your Gadget Cool
- Israel says soldiers wounded in Gaza fighting amid fragile truce
- Displaced Palestinian families suffer as heavy rains flood Gaza tent camps
