(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
Argentina reportedly delaying embassy move over Israeli company's oil project near Falklands - 2From Certificate to Dollars: College Majors with Extraordinary Monetary Prizes
- 3Steven Spielberg's 'Disclosure Day' trailer drops: What we know about the alien movie
- 4Defence chiefs of Thailand and Cambodia to discuss ceasefire
- 5Slims down for Maintainable Weight reduction
- Parents speak out as 4-year-old fights button battery injury in intensive care unit
- Shipping: The Corridors of Trade and the Coming of Another Period
- Air Force made critical errors during October 7 massacre, investigator says
- Discovery off Israel’s coast reveals earliest known 2,600-year-old shipment of raw iron
- Most loved Well known Accessory Styles For 2024
- Relive NASA's historic Artemis 2 launch to the moon in these stunning photos
- At UN climate conference, some activists and scientists want more talk on reforming agriculture
- Saudi Arabia says it intercepted 7 missiles, debris falls near energy facilities
- Embrace Effortlessness: Moderation and Cleaning up Tips
