FDA Approves AstraZeneca's Epanova For Severe Hypertriglyceridaemia

AstraZeneca announced in a press release that the Food and Drug Administration (FDA) has approved Epanova (omega-3-carboxylic acids). The prescription drug is used in conjunction with diet to reduce triglyceride levels in adults with severe hypertriglyceridemia. The FDA based its approval in part on the success of Phase III EVOLVE trials. Briggs Morrison, EVP of Global Medicines Development and CMO at AstraZeneca said, “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.”

Epanova

AstraZeneca acquired Epanova from Omthera Pharmaceuticals in 2013. Originally intended to treat Crohn’s disease, the compound was found ineffective for that condition. Epanova is an omega-3 in free fatty acid form — the first FDA approved compound in that form. Patients can opt to take daily doses of 2 grams in two capsules or 4 grams in 4 capsules, either with or without food. The compound is composed of 60 percent EPA and 15-25 percent DHA derived from wild fish sources. The capsule is patent-protected with a proprietary delivery method that maximizes bioavailability and tolerability.

Epanova Trials

The FDA approved Epanova after reviewing data from the Phase III EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) trial. Investigators tested Epanova for its ability to lower triglycerides and otherwise positively influence lipid parameters. AstraZeneca is conducting cardiovascular trials with the drug, called STRENGTH (STatin Residual risk reduction with EpaNova in hiGh cardiovascular risk paTients with Hypertriglyceridemia). The company is evaluating Epanova along with statin therapy in patients with mixed dyslipidemia and is filing for regulatory approval for the severe hypertriglyceridemia indication in other countries.

Severe Hypertriglyceridemia 

Severe hypertriglyceridemia is when triglyceride levels are greater than or equal to 500 mg/dL. People with high levels of triglycerides have high levels of fat in the blood, which leads to serious health problems. In the U.S., about four million people have severe hypertriglyceridemia. Additionally, with diabetes and obesity rising, severe hypertriglyceridemia rates are expected to rise. AstraZeneca and the FDA believe that Epanova is a viable option to manage triglyceride levels along with a healthy diet.