- Amarin will get a regulatory decision sooner than expected on an important label expansion for its fish oil-based pill, Vascepa. The company said Wednesday the Food and Drug Administration will decide by Sept. 28 on approving the drug for treating heart risk.
- The sped-up timeline comes courtesy of a priority review granted by the FDA, setting up a potential approval in late 2019 rather than early 2020. News of the faster regulatory clock sent Amarin's stock up by as much as 15% Wednesday morning.
- The Ireland-based biotech is still waiting, however, on further word from the agency on whether its application will require an advisory committee review, a critical step in the process that could bring heightened scrutiny on Vascepa.
If approved, Vascepa (icosapent ethyl) would be the latest entrant aimed at reducing the heart risk of patients already taking statins, following the introduction of PCSK9 therapy in 2015.
In a late-stage study called REDUCE-IT, treatment with Amarin's drug led to a 25% reduction versus placebo in the relative risk of major heart events like heart attack or stroke, when given on top of statin therapy.
Those results, first announced last September, transformed Amarin from a company worth $885 million to its current valuation of more than $6 billion today.
Even without a label expansion, the REDUCE-IT results have driven a steady rise in Vascepa prescriptions. Total prescriptions for the drug have increased 67% year over year, according to data through May 17 cited by Cantor Fitzgerald analyst Louise Chen.
Jefferies analyst Michael Yee, writing in a May 29 note to investors, expects sales to grow to $90 million or more in the second quarter. Vascepa earned Amarin $77 million over the first three months of the year.
While Vascepa prescriptions and sales have grown since REDUCE-IT, the pill has also faced questions. The full data, published last November, showed the mineral oil placebo used as a control may have raised average levels of two key biomarkers.
Some cardiologists have questioned if that result may have exaggerated the magnitude of Vascepa's benefit by making the placebo group worse off — a concern an advisory committee would likely debate, if convened by the FDA.
The company said in a statement the FDA did not indicate whether or not there would be such a meeting, but Amarin executives have said one is likely.
CEO John Thero said Amarin will expedite its plans to market Vascepa under a potential new label to reflect the September decision date.