(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
Shredded cheese recall: Multiple brands sold at Aldi, Target and Walmart affected over potential metal fragment contamination - 22 of Earth's rarest lightning phenomena captured simultaneously in once-in-a-lifetime photo
- 3France bans Muslim gathering citing risk to participants
- 4Flourishing as a Charitable Pioneer: Individual Encounters in Generosity
- 5EU health regulator urges immediate vaccinations amid early surge in flu cases
- Could the Star of Bethlehem have actually been a comet?
- The powerful new Rubin Observatory just found 11,000 new asteroids and measured 'tens of thousands more'
- Seoul says sorry after unapproved drone flights into North Korea
- 1st human missions to Mars should hunt for signs of life, report says
- Vote in favor of the Web-based Work out schedule to Keep You Fit and Sound
- US measles cases surpass 2,000, highest in 30 years: CDC
- Conquering Social Generalizations: Individual Accounts of Strengthening
- Terminal cancer diagnosis announced by JFK's granddaughter
- Mickey Lee of 'Big Brother' fame dead at 35 after flu complications, family says
