A prescription pill derived from fish-oil received the regulatory nod Friday to expand its use as a supplementary treatment, alongside statins, to more patients at risk of heart attack or stroke.
The FDA approved the Amarin Pharma drug, icosapent ethyl (Vascepa), for use as a secondary treatment for adults who are taking statins and have elevated levels of triglycerides, a type of fat in the blood. Those patients must also have established heart disease or diabetes, and two or more additional heart disease risk factors.
High levels of triglycerides can contribute to an increased risk of heart attack or stroke by hardening the arteries or thickening the artery wall. Heart attack is the leading cause of death of men and women in the US; stroke ranks fifth.
Amarin (NASDAQ: AMRN) stock rose about 7 percent in after-hours trading to about $26 per share. The company is based in Bedminster, NJ, but headquartered in Ireland for tax purposes.
In 2012, Vascepa was approved for patients with very high triglyceride levels; it was Amarin’s first FDA-approved treatment. Last month an FDA advisory committee unanimously recommended the agency OK the prescription pill for use in an expanded population, those with elevated triglyceride levels. The FDA said in its announcement Friday that its decision on Vascepa makes the pill the first approved drug for reducing cardiovascular risk in patients who have these high triglyceride levels.
The active ingredient in Vascepa is eicosapentaenoic acid, an omega-3 fatty acid. Amarin doesn’t know exactly how its drug works to provide cardiovascular benefit, but in clinical trials of more than 8,000 high-risk patients, the pill reduced the likelihood of a heart attack or stroke by 25 percent.
The most common side effects were musculoskeletal pain, swelling of legs and hands, atrial fibrillation, and joint pain. Read more about the study’s results, announced last year, here.
Amarin reported total revenue in the first nine months of the year of $286.5 million, 89 percent more than in the same months the year before. Last month the company said it had doubled its number of sales representatives to 800 in anticipation of an FDA approval and subsequent launch of the drug in the expanded patient population at the start of 2020.
On Friday the company raised its revenue projection for 2020 to the range of $650 million to $700 million. It didn’t provide estimates for subsequent years, but said it anticipates the drug will earn it “multiple billions of dollars.”