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Amarin's Vascepa MAA for Heart Risk Indication Accepted in EU

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Amarin Corporation plc AMRN announced that the European Medicines Agency has validated and accepted its marketing authorization application (“MAA”) for Vascepa (icosapent ethyl). The MAA seeks approval for the drug in Europe as a treatment to reduce the risk of cardiovascular events in high-risk patients with cholesterol levels controlled with statin treatment but elevated triglycerides and other cardiovascular risk factors.

The regulatory application includes data from previously completed REDUCE-IT cardiovascular outcomes study. The review of the MAA is expected to be completed before the end of 2020. The drug is not approved for any indication in Europe.

Vascepa is already approved in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. A supplemental new drug application (sNDA) seeking label expansion of the drug in the United States to include data from the REDUCE-IT study is under priority review. Earlier this month, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously (16-0) to approve the label expansion for Vascepa. A decision from the FDA is expected by Dec 28, 2019.

Shares of Amarin have soared 57.2% so far this year compared with the industry's growth of 5.4%.

Data from the REDUCE-IT study demonstrated that patients treated with Vascepa achieved a statistically significant relative risk reduction of 25% in the first occurrence of a major adverse cardiovascular event (“MACE”) compared to placebo. A composite of cardiovascular death, nonfatal myocardial infarction (heart attack), nonfatal stroke, coronary revascularization (procedures such as stents and by-pass) and unstable angina requiring hospitalization were represented as MACE in the study.

Per the press release, there are millions of patients in Europe with persistent cardiovascular risk beyond standard-of-care statin therapy. More than 1.8 million people die every year due to MACE in European Union (“EU”). Cardiovascular disease is estimated to cost the EU economy €210 billion a year, as stated in the press release.

The currently available therapies in Europe reduce cardiovascular risk by lowering LDL-C (bad cholesterol) levels. However, there is no treatment available to treat high levels of triglycerides as an adjunct to statin therapy in dyslipidemic patients in Europe.

In the first nine months, sales of Vascepa, completely from the United States, surged nearly 90% year over year to $285 million. Potential approval in Europe and a label expansion in the United States is likely to drive sales of the drug higher.

Zacks Rank & Key Picks

Amarin currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the biotech sector are Alkermes plc ALKS, Anika Therapeutics Inc. ANIK and BioDelivery Sciences International, Inc. (BDSI - Free Report) . While Alkermes and Anika sport a Zacks Rank #1 (Strong Buy), BioDelivery carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings estimates increased from 36 cents to 52 cents for 2019 and changed from a loss of 11 cents to earnings of 59 cents for 2020 over the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average beat being 236.8%.

BioDelivery’s loss estimates have narrowed from 26 cents to 16 cents for 2019. For 2020, earnings estimates moved up from 19 cents to 31 cents for 2020 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average beat being 159.38%. Share price of the company has increased 87% so far this year.

Anika’s earnings estimates increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, the average beat being 53.31%. Share price of the company has increased 68.3% so far this year.

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