(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)
The Response to Independence from the rat race: Methodologies for Creating Financial momentum- Figure out how to Guarantee Your Dental Embeds Endure forever
- Top 20 Compelling Business Books for Progress
- Who is Artemis? Meet the Greek goddess who inspired NASA's return to the moon
- Anthony Joshua's driver charged over Nigeria crash that killed two
- Geminid meteor shower, one of the year's most reliable, peaks this weekend
- Going with Children: Tips for Tranquil Family Get-aways
- Dave Coulier shares new cancer diagnosis 1 year after revealing previous diagnosis
- Vote In favor of Your Favored Cereal
