US FDA approval for AstraZeneca's Epanova

There was good news today for Anglo-Swedish drug major AstraZeneca (LSE: AZN), as the US Food and Drug Administration has approved the firm’s Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).

Epanova was acquired by AstraZeneca along with its purchase last year of US firm Omthera Pharmaceuticals, in an up to $443 million ($323 million upfront) deal (The Pharma Letter May 28, 2013). Itis the first FDA approved prescription omega-3 in free fatty acid form. The dosage of Epanova is 2 grams (2 capsules) or 4 grams (4 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.

“The FDA’s approval of Epanova is good news for the significant and growing population with severe hypertriglyceridemia as it offers physicians and their patients an important new treatment option that has been proven to be effective in clinical trials,” said Briggs Morrison, executive vice president, global medicines development and chief medical officer at AstraZeneca. “This approval is a significant milestone for AstraZeneca, as it strengthens our existing portfolio of cardiovascular medicines. We are committed to further assessing the clinical profile of Epanova and to identifying other patient groups it may benefit,” he added.