
(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
Bowen Yang is reportedly leaving 'Saturday Night Live' after this week's episode - 2
She's been a Bond girl and a mutant. Now she's grappling with Hollywood's obsession with 'eternal youth.' - 3
Instructions to Amplify Certifiable Experience While Chasing after an Internet Advertising Degree - 4
Find the Marvels of the World with These Travels - 5
Astronomers discover never-before-seen celestial object: "Cloud 9"
UK can legally stop shadow fleet tankers, ministers believe
‘I love this work, but it’s killing me’: The unique toll of being a spiritual leader today
Find the Lively Food Markets of South America
Portable Installment Answers for Independent ventures
'Home Alone' actor Joe Pesci said 'no' to this stunt until he saw a 9-year-old girl do it, says director Chris Columbus
Favored Vehicle for Seniors: Make Your Determination
At UN climate conference, some activists and scientists want more talk on reforming agriculture
Research highlights potential dangers of ultra-processed foods for women under 50 regarding precancerous polyps
Defense Minister Katz moves to extend IDF service to 36 months











