- A Food and Drug Administration expert panel on Thursday unanimously recommended that the agency expand the label of Amarin's Vascepa to include risk reduction for cardiovascular events, validating blockbuster ambitions for the fish oil-based pill.
- By gaining the support of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, Amarin cleared a major barrier in its path to expanding Vascepa's market. The company's add-on application is based on Phase 3 results that showed Vascepa cut the risk of major heart events by 25% versus placebo.
- Results from that study, dubbed REDUCE-IT, transformed Amarin overnight from an $885 million company into one valued at $3 billion. Over the last 12 months, as Vascepa prescriptions and sales steadily increased, likely through off-label use, Amarin kept growing in value. Going into Thursday, with trading halted for the day, the company held a market value of about $7.7 billion.
With the advisory committee now behind it, Amarin's next test will be the exact labeling language used by the FDA, assuming the agency follows through and approves a label expansion.
The FDA has set a deadline of Dec. 28 to decide on Amarin's application for Vascepa (icosapent ethyl). And while the label specifics will be important in setting the drug's commercial potential, which Wall Street analysts forecast as a blockbuster in the making, Thursday's unanimous vote should lay to rest some of the debate around the REDUCE-IT data.
In particular, the use of a mineral oil placebo stirred controversy among some investors and physicians, who questioned if it may have interfered with the effectiveness of the statins patients were on during the trial.
While Vascepa patients saw a mean LDL cholesterol increase of 3.1% throughout the study, the placebo group saw bad cholesterol go up 10.2%.
Amarin defended its choice of mineral oil through detailed, post-hoc data analyses as well as pointing to the FDA's acceptance of the choice through special protocol agreements.
Instead, the committee's input may help guide the label Amarin receives. Jefferies analyst Michael Yee wrote the committee split about 50-50 on label details, with half wanting a broader expansion and half seeking a more restricted choice to the 70% of patients who showed the biggest benefit in REDUCE-IT.
Pending an FDA approval later this year, Amarin plans to double its sales force from 400 to 800 representatives. Company executives have also outlined plans to boost its direct-to-consumer advertising push with the expanded label.