US FDA accepts Epanova NDA filing
Anglo-Swedish drug major AstraZeneca (LSE: AZN) today announced that the US Food and Drug Administration (FDA) has accepted for review a New Drug Application for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).
The NDA submission for Epanova was filed by USA-based Omthera Pharmaceuticals, which AstraZeneca acquired for an upfront $323 million, in a deal worth a potential $433 million including contingency payments (The Pharma Letter May 28), as a 505(b)(1) application in July 2013. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is May 5, 2014.
Omthera holds worldwide rights to Epanova under a license from Chrysalis Pharma AG, a privately held Swiss company that is the owner of the product.
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