FDA approves AstraZenecas fish oil drug

Astrazeneca receives federal approval for Epanova, adding another prescription fish oil pill to the market.  

The FDA recently approved another omega-3 fish oil drug from big pharma: AstraZeneca’s Epanova.

The drug is the first FDA-approved prescription omega-3 in free fatty acid form. The dosage of Epanova is two grams (two capsules) or four grams (four capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a day, with or without food. Epanova joins GlaxoMisthKline’s Lovaza and Amarin’s Vascepa as fishy options for docs to prescribe.

Motley Fool’s senior biotech specialist Brain Orelli and health-care analyst David Williamson talk about the “weird” market dynamics for fish oil drugs in a segment of “Biotech Banter.” Epanova’s designed to use as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500 mg/dL). The population of people with severe hypertriglyceridaemia is relatively low (four million), explains Williamson, compared to the population of people with moderate hypertriglyceridaemia, the market the drug company is aiming for in the future. This approval seems one step in a larger plan, according to the Fool’s analysts.

“We'll have to see whether AstraZeneca can use its marketing muscle to succeed where Amarin has failed,” writes Orelli on the Fool’s site. “Epanova has some advantages because it can be taken just once a day and doesn't have to be taken with food, but it's debatable whether those are big enough to get patients to switch.”

Gotta wonder, however, what marketing muscle named the drug. “No va” means “no go” in Spanish. “EPA no go” doesn’t seem like the most optimistic moniker for a new fish oil pill.

In the meantime, spotlight on a new prescription fish oil pill may spill over onto existing OTC options.

Sales of Epanova are expected to reach at least $322 million a year by 2018, according to TechTimes.com.

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