AstraZeneca EPA approved by FDA

Source: China Association for the promotion of drugs 2014-05-06 AstraZeneca announced that the US FDA has approved epanova (ω - 3-carboxylic acid) as an adjuvant therapy for diet to reduce the level of triglycerides in patients with severe hypertriglyceridemia (triglyceride level ≥ 500mg / dl) Epanova is the first FDA approved omega-3 prescription drug in the form of free fatty acids The company said FDA approval of the drug was based on clinical development data from a phase III evolve trial that included positive results that examined the efficacy of epanova in reducing triglycerides and other key lipid parameters in patients with hypertriglyceridemia Briggs Morrison, chief medical officer and executive vice president of global drug development at AstraZeneca, said: "this approval is an important milestone for AstraZeneca because it strengthens our existing cardiovascular drug portfolio We are in the process of further evaluating the clinical data of epanova to identify other patient groups that may benefit from the drug " AstraZeneca plans to evaluate the safety and efficacy of combination therapy of epanova and statins in patients with mixed hyperlipidemia and increased risk of cardiovascular disease in order to reduce the risk of cardiovascular disease AstraZeneca has also proposed plans to develop a fixed dose combination of epanova and statins, as well as to submit applications to regulators in other markets for severe hypertriglyceridemia indications Original link: http://www.rttnews.com/2315022/astrazeneca-announcements-fda-approval-for-epanova-quick-facts.aspx