(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
EPA watchdog finds nation’s most contaminated sites are vulnerable to flooding, wildfires - 2The pace of hiring just fell to the lowest since 2011, outside of the pandemic
- 3Find the Insider facts of Compelling Systems administration: Building Associations for Progress
- 4Avoid Large Crowds In Bali & Swim At This Peaceful Waterfall With A Gorgeous, Natural Pool
- 5Boats escort freed whale away from shallow waters off German coast
- French lawmakers narrowly approve health care budget, suspending Macron's flagship pension reform
- Tech giants accused of not complying with Australian social media ban
- Images of Bangladeshi motorcyclists sleeping at petrol pumps are AI-generated
- 'Always put others first': IDF reservist who died while on leave saves four with organ transplants
- AI is providing emotional support for employees – but is it a valuable tool or privacy threat?
- Bolsonaro briefly leaves Brazilian prison for medical tests after a fall from his bed
- Foreign military officials can become Israel's ambassadors, senior IDF commander tells 'Post'
- Father and son spending Christmas together after health scares
- 1,000-mile Saharan dust storm, from the sky and from the ground
