AstraZeneca announced that the FDA (U.S. Food and Drug Administration) approved Epanova as a diet supplement to reduce triglyceride levels in patients with severe hypertriglyceridemia.
AstraZeneca won the approval for its new medication for heart diseases called Epanova, fighting a takeover from Pfizer Inc. worth $106 billion. The FDA approved the new pill based on a clinical development program data that showed positive results after Phase III EVOLVE which tested the effects of Epanova in reducing triglycerides and other lipid factors in patient suffering from high triglycerides.
The fish oil-based drug market is already crowded and Epanova's commercial potential might be limited. It is designed to treat people with very high fatty triglyceride levels in their blood, developed originally by Omthera Pharmaceuticals before AstraZeneca acquired it in 2013 for $443 million. Epanova will compete against GlaxoSmithKline's Lovaza and Amarin's Vascepa. Epanova is expected to reach at least $322 million a year of sales by 2018.
"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," said AstraZeneca's Exec. Vice Pres. and Chief Medical Officer for Global Medicines Development Briggs Morrison
Patients must be on an appropriate lipid-reducing diet before they can receive Epanova. They must also continue the special diet during their Epanova treatment. Patients should undergo lab tests to ascertain whether triglyceride levels are consistently abnormal before they start the Epanova therapy. To control serum lipids, the treatment should include exercise, appropriate diet, weight loss for obese patients and control of other medical problems such as hypothyroidism and diabetes mellitus which contribute to abnormal triglyceride levels.
Drugs that exacerbate hypertriglyceridemia including thiazides, beta blockers and estrogens should be modified or discontinued before starting the Epanova therapy, if possible. To date, how Epanova affects one's risk for pancreatitis and cardiovascular morbidity and mortality have not been determined.
AstraZeneca aims to develop a fixed and combined dose of Epanova and its cholesterol-reducing drug Crestor. If the new combination becomes successful, the drug would extend the Crestor franchise even after 2016, when its U.S. patent will end.