AstraZeneca announced Monday that it will close a Phase III study of Epanova (omega-3 carboxylic acids) due to its "low likelihood" of demonstrating a benefit in patients with mixed dyslipidaemia who are at increased risk of cardiovascular (CV) disease. Mene Pangalos, executive vice president of biopharmaceuticals R&D, said "we are disappointed by these results, but…it was important to assess the potential benefit of Epanova in mixed dyslipidaemia."
According to the company, the independent data monitoring committee for the STRENGTH trial recommended to discontinue the study as Epanova was unlikely to demonstrate a benefit. The CV outcomes trial was designed to evaluate the efficacy of Epanova compared to placebo, both in combination with standard-of-care statin medicines, on reducing the risk of major adverse CV events in 13,086 patients with mixed dyslipidaemia and at high risk for CV disease. Full data from the study will be presented at a forthcoming medical meeting.
AstraZeneca gained Epanova in 2013 via the purchase of Omthera Pharmaceuticals, with the omega-3 free fatty acid composition gaining FDA clearance the following year as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia. The UK drugmaker indicated on Monday that it is reviewing the ongoing value of the $533-million Epanova intangible asset, with a write down of up to $100 million related to inventories anticipated to impact core earnings in the fourth quarter of 2019.
Analysts predict that Epanova will generate sales of $145 million in 2023. However, Citi analyst Andrew Baum noted that as the drug's estimated contribution to future sales is relatively modest, the STRENGTH trial results "should have limited negative share price impact." Still, he suggested that Epanova would have "rounded out AstraZeneca's growing suite of differentiated CV disease assets," citing the heart disease drug Brilinta (ticagrelor) and diabetes therapy Farxiga (dapagliflozin), which is also approved for heart failure, as well as the anaemia treatment roxadustat.
The disappointing results for AstraZeneca's therapy come shortly after the FDA expanded approval of Amarin's fish-oil-derived drug Vascepa (icosapent ethyl) to include use as an adjunctive therapy to lower the risk of CV events in adults with triglyceride levels of 150 mg/dL or more. The authorisation was based on findings from the REDUCE-IT CV outcomes trial, with results showing that Vascepa was associated with a 30% risk reduction in total major adverse CV events compared to placebo.
For related analysis, see Physician Views snap-poll results – Cardiologist feedback points to significant uplift for Amarin's Vascepa.
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