Amarin’s fish-oil pill now available to millions more patients. But it’s still no Lipitor - (MarketWatch via NewsPoints Desk)

  • A long-awaited label expansion puts Amarin's Vascepa on track for millions in new sales, but the new indication also comes with a more limited scope than what the Irish drugmaker had been aiming for, reported MarketWatch.

  • The FDA first approved Vascepa in 2012 as a treatment for very high triglycerides. With the new indication, Amarin can market Vascepa, its only product, to lower the risk of cardiovascular events in patients with high triglyceride levels who are already taking statins.

  • However, this is a much smaller patient population than what some analysts had predicted. If the indication had included those with mild-to-moderate triglyceride levels, that would have expanded the market to an estimated 40 million patients, according to Maxim Group analysts.

  • Instead, Oppenheimer's Leland Gershell believes the number of patients who can now be prescribed Vascepa is between 5 million and 8 million people in the US, up from the roughly 4 million patients who fit the original product label. 

  • Analysts have estimated Amarin's revenue to be $410 million in 2019 and $654 million in 2020, falling in range of the company's revised guidance in light of the new label, while Stifel had estimated $3 billion in annual peak sales for Vascepa, based on a market of 10 million to 15 million patients.

  • Meanwhile, Pfizer's Lipitor was once the world's top-selling drug, bringing in annual sales of $12 billion. However, since then, a small number of cardiovascular drugs to come to market have struggled to establish themselves, including Sanofi and Regeneron Pharmaceuticals' Praluent and Amgen's Repatha, both PCSK9 inhibitors, as well as Novartis' heart-failure drug Entresto.

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