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AstraZeneca to End Phase III Study on Fish Oil Heart Drug

ZacksJanuary 14, 2020, 2:46 PM UTC. AstraZeneca plc AZN announced plans to discontinue a late-stage outcomes study evaluating its cholesterol medicine, Epanova to reduce the risk of cardiovascular disease in patients with mixed dyslipidaemia (MDL) or high triglyceride (TG) levels. Epanova, a fish oil derived tablet, is presently marketed in the United States as an adjunct to diet to reduce TG levels in adult patients with severe hypertriglyceridemia. If the STRENGTH study would have been successful and Epanova was subsequently approved for the CV indication, it would have broadened the drug’s label and made it eligible to treat an expanded patient population and thereby bring in higher sales. AstraZeneca said it would take a charge of up to $100 million related to inventories, which will hurt its earnings in the fourth quarter. Meanwhile, another company, Acasti Pharma ACST announced that a phase III study evaluating its krill oil derived candidate CaPre for the treatment of severe hypertriglyceridemia failed to reach statistical significance for the primary endpoint of reducing triglycerides by 20%. Acasti's stock plummeted 65% on Monday in response. However, gaining from AstraZeneca and Acasti’s failures, shares of Amarin Corporation AMRN were up 4.2% on Monday as its fish-oil derived drug Vascepa was approved to lower CV risk in patients with high triglyceride levels late last year.

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