US FDA accepts AstraZeneca’s NDA for Epanova

AstraZeneca has announced that the US FDA has accepted its New Drug Administration (NDA) for its new heart drug Epanova for review.

Epanova is an investigational compound for the treatment for patients with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500mg/dL).

The US submission includes data from phase 3 clinical trials that investigated the safety and efficacy profile of the fish oil-based drug. Positive results showed that Epanova was effective in lowering very high triglycerides and in reducing non-HDL cholesterol in combination with a statin for patients with very high triglycerides.

The NDA submission for Epanova was filed in July 2013 by Omthera Pharmaceuticals, which is now a wholly-owned subsidiary of AstraZeneca.

The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is 5th May 2014.


Related news:

AstraZeneca looks for new heart drug approval by next May (Reuters)

Reference links:

AstraZeneca press release

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