The FDA accepted AstraZeneca's filing seeking approval of its investigational therapy Epanova, a complex mixture of polyunsaturated free fatty acids derived from fish oils, for the treatment of patients with severe hypertriglyceridaemia, the company reported Wednesday. AstraZeneca noted that the agency is scheduled to make a decision on the compound by May 5 next year.
The marketing application for Epanova was submitted in July by Omthera Pharmaceuticals, which AstraZeneca subsequently acquired for around $323 million. The application included positive results from two Phase III trials, both demonstrating that Epanova significantly lowered triglycerides (TG) and non-HDL cholesterol levels in patients with high TGs. Specifically, the EVOLVE study enrolled 399 patients with fasting TG levels of at least 500 mg/dL, but less than 2000 mg/dL, while the ESPRIT trial tested Epanova as an add-on to statin therapy among 647 patients with persistent hypertriglyceridaemia and high risk for cardiovascular disease.
Omthera holds global rights to Epanova under a license from Chrysalis Pharma. AstraZeneca is also developing a fixed-dose combination of Epanova with Crestor (rosuvastatin).
For related analysis, read Physician Views Poll Results – Cardiologists keen to broaden usage of prescription fish oil treatments for dyslipidaemia as competition in market intensifies via AstraZeneca’s acquisition of Omthera and ViewPoints: AstraZeneca advances its bolt-on M&A strategy, but are analysts getting jittery?
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