PDUFA date set for volanesorsen
The Prescription Drug User Fee Act (PDUFA) date for volanesorsen, an investigational therapy for the treatment of familial chylomicronemia syndrome (FCS), has been set by the US Food and Drug Administration for August 30 this year.
Under development at biotech firm Akcea Therapeutics (Nasdaq: AKCA),a spin-out from Ionis Pharmaceuticals (Nasdaq: IONS), volanesorsen is the first ever to show reduction in the occurrence of pancreatitis events compared to placebo in a select patient population with a history of multiple attacks.
The New Drug Application (NDA) was filed by Akcea in August 2017. Jefferies' analyst Eun Yang expects peak sales of around $150 million for the drug.
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