FDA Approves Novel Drug for Severe Hyperglyceridemia

May 6, 2014
Rachel Lutz

A hypertriglyceridemia drug from AstraZeneca has been approved by the US Food and Drug Administration.

The US Food and Drug Administration (FDA) has approved a severe hypertriglyceridemia drug to work in conjunction with diet in adults, AstraZeneca announced.

As the first FDA-approved drug of its kind in free fatty acid form, Epanova (omega-3-carboxylic acids) is available in doses of 2 or 4 grams in the form of 2 or 4 capsules, respectively, that can be taken with or without food.

The FDA approval was based on data from the Phase 3 Epanova for Lowering Very High Triglycerides (EVOLVE) trial, which examined the medication’s effectiveness in reducing triglyceride levels ≥500 mg/dL. However, the drug has not been tested for risk of pancreatitis or cardiovascular mortality and morbidity.

“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,” Briggs Morrison, Executive Vice President of Global Medicines Development and Chief Medical Officer of AstraZeneca, said in a press release. “This approval … 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.”