Takeda Gets FDA Approval For Blood-Clotting Disorder Treatment
10 November 2023 - 7:25AM
Dow Jones News
By Ben Glickman
Takeda's treatment for a rare blood clotting disorder received
approval from the U.S. Food and Drug Administration.
The FDA said Thursday it approved Adzynma, a genetically
engineered protein product for enzyme replacement therapy, to treat
adults and children with congenital thrombotic thrombocytopenic
purpura.
The disorder, caused by a genetic mutation, causes blood clots
to form in small blood vessels around patients' bodies and is
estimated to affect fewer than 1,000 people in the United
States.
Patients can have severe bleeding episodes, strokes or damage to
organs, and the disease may be fatal if untreated.
The FDA said the efficacy and safety of Adzynma had been
demonstrated in a study comparing the treatment to plasma-based
therapies in patients with cTTP.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
November 09, 2023 15:10 ET (20:10 GMT)
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