Amarin Corporation plc (AMRN - Free Report) announced that the FDA has granted priority review to the supplemental new drug application (sNDA) for its sole marketed drug, Vascepa. The sNDA is looking to expand Vascepa’s label as a treatment for reduction of residual cardiovascular risk in patients with persistent elevated triglycerides on statin therapy for LDL-C (bad cholesterol). A decision on approval is expected by Sep 28, 2019.
A potential approval to the label expansion will make Vascepa the first drug for the indication.
Please note that Vascepa is already approved in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Shares of Amarin rallied 11.6% on May 29 following the news. Amarin’s shares have gained 29.6% so far this year compared with the industry’s increase of 0.9%.
The sNDA includes data from the late-stage cardiovascular outcomes study – REDUCE-IT. In March, Amarin presented updated data from the study, which showed that the drug led to a significant reduction in cardiovascular risk in patients with LDL-C controlled by statin therapy. The relative risk of major adverse CV events (“MACE”) was reduced by 30% upon treatment with Vascepa compared to placebo.
Vascepa also led to a 26% reduction in key secondary composite endpoint of cardiovascular death, heart attacks and stroke. The study also achieved the additional secondary endpoints including reductions in cardiovascular death (20%), fatal or nonfatal heart attacks (31%), fatal or nonfatal stroke (28%), urgent or emergent coronary revascularization (35%) and hospitalization for unstable angina (32%).
Upon potential approval, the drug will face competition from Sanofi (SNY - Free Report) and Amgen’s (AMGN - Free Report) PCSK9 inhibitors, Praluent and Repatha, respectively.
Zacks Rank and Stock to Consider
Amarin is a Zacks Rank #3 (Hold) stock. A better-ranked stock in the biotech sector is Anika Therapeutics Inc. (ANIK - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have been revised 4.9% upward for 2019 and 9.9% for 2020 over the past 60 days. The stock has gained 13.3% so far this year.
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