AstraZeneca’s EPANOVA receives FDA approval for treatment of adults with hypertriglyceridemia

AstraZeneca (NYSE: AZN) today announced the US Food and Drug Administration (FDA) approved 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 500 mg/dL).

EPANOVA is 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. It can be taken with or without food.

"The FDA 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 Dr. Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca. "This approval is a significant milestone for AstraZeneca, as it strengthens our existing portfolio of medicines. We are committed to further assessing the clinical profile of EPANOVA and identifying other patient groups it may benefit."

Triglycerides are a type of lipid (fat) found in blood and an essential energy source for the body. Some people have very high triglyceride levels (severe hypertriglyceridemia), meaning they have too much fat in their blood and that can lead to serious health complications. Nearly four million American adults currently have severe hypertriglyceridemia and this figure continues to increase along with the incidence of associated conditions, such as obesity and diabetes.

"Patients with severe hypertriglyceridemia often have other medical conditions, such as diabetes and high blood pressure, that require them to take multiple medications," said Dr. Michael Davidson, Executive Vice President, Omthera Pharmaceuticals, an AstraZeneca company. "Although physicians will treat each patient individually, EPANOVA offers physicians a two-capsule dosing option, once a day with or without food. This provides physicians with a simple, patient-friendly option to effectively manage this serious condition without dramatically increasing a patient's pill burden when prescribing the two gram dose."

The FDA approval was based on data from a clinical development program that included positive results from the Phase III EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial, which examined the efficacy of EPANOVA in lowering triglycerides and other key lipid parameters in patients with very high triglycerides. The effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined.

AstraZeneca is committed to assessing the impact of lowering triglycerides and further evaluating the clinical profile of EPANOVA. Through a large-scale trial, STRENGTH (a long-term outcomes study to assess STatin Residual risk reduction with EpaNova in hiGh cardiovascular risk paTients with Hypertriglyceridemia), AstraZeneca will evaluate the safety and efficacy of EPANOVA on cardiovascular outcomes in combination with statin therapy in patients with mixed dyslipidemia at increased risk of cardiovascular disease. AstraZeneca also plans to pursue the development of a fixed dose combination of EPANOVA with a statin and plans to file for regulatory approval in other markets for the severe hypertriglyceridemia indication.

Important Safety Information for EPANOVA^® (omega-3-carboxylic acids) Capsules

• EPANOVA is contraindicated in patients with known hypersensitivity to EPANOVA or any of its components
• In some patients, EPANOVA increases LDL-C levels. LDL-C levels should be monitored periodically during therapy with EPANOVA. In patients with hepatic impairment, ALT and AST levels should be monitored periodically during therapy with EPANOVA
• EPANOVA should be used with caution in patients with known hypersensitivity to fish and/or shellfish
• Some published studies with omega-3-acids demonstrated prolongation of bleeding time, which did not exceed normal limits and did not produce clinically significant bleeding episodes. Patients taking anti-platelet agents or anticoagulants were excluded from EPANOVA clinical trials involving patients with hypertriglyceridemia. Nonetheless, patients receiving treatment with EPANOVA and an anticoagulant or other drugs affecting coagulation (eg, anti-platelet agents) should be monitored periodically
• Most common adverse reactions with EPANOVA 2 grams and 4 grams, respectively, were diarrhea (7%, 15%), nausea (4%, 6%), abdominal pain or discomfort (3%, 5%) and eructation (3%, 3%)