Fierce Pharma February 23, 2024
A narrow miss in a confirmatory trial has threatened to undo Travere Therapeutics’ accelerated approval in the United States for Filspari (sparsentan) as a treatment for IgA nephropathy (IgAN).
But that hasn’t stopped the Europe’s Committee for Medicinal Products for Human Use (CHMP) from recommending it for full approval in the condition, which is also known as Berger’s disease.
The CHMP opinion clears the way for Filspari to receive full approval to treat the disease which can cause kidney failure, requiring dialysis or a kidney transplant.
Approved on an accelerated basis by the FDA in February of last year as a first-in-class treatment for IgAN, Filspari came up just short in a confirmatory trial comparing it to irbesartan. While it...
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