- While Amarin waits for the Food and Drug Administration to grant an expanded label for Vascepa, one leading medical organization has already seen enough to be convinced by the merits of the fish oil pill.
- On March 28, the American Diabetes Association amended its medical care standards to include the drug for diabetics who also have cardiovascular (CV) disease. While not an endorsement by the ADA, the group's practice committee recommended doctors consider Vascepa as a way to reduce CV risk.
- The ADA update was based on recent Phase 3 study results, which showed the drug reduced the relative risk of the first occurrence of a major adverse CV event by 25% and the total number of CV events by 30%. Amarin's stock climbed more than 15% off the news, opening Thursday at $19.75 per share.
The Phase 3 REDUCE-IT trial has transformed Amarin, sending the company's value up significantly and raising Wall Street speculation over a potential buyout from a big pharma.
While not a direct endorsement, the ADA's inclusion of Vascepa (icosapent ethyl) in its annual standards of medical care documents provides some validation for the fish oil pill.
The topline readout last September gained considerable attention from cardiologists by showing a 25% risk reduction for CV events in addition to statin therapy.
Fuller data, however, tempered that enthusiasm, with some heart experts raising questions about what effects the trial's mineral oil placebo may have had on the final results.
Amarin presented a new post-hoc analysis at the American College of Cardiology's annual conference earlier this month. While it didn't address placebo questions or how Vascepa actually works, the number crunching showed the drug reduced the total number of CV events by 30% compared to placebo.
That body of evidence has convinced ADA's 14-person practice committee, which recommended doctors consider Vascepa for diabetic patients with atherosclerotic cardiovascular disease who are on a statin and have controlled LDL-C but elevated triglycerides. Notably, the recommendation is not equivalent of ADA endorsement or approval of Vascepa, according to Amarin.
The group's conclusion also comes before the FDA weighs in on the expanded use of Vascepa. Currently, it is approved to reduce very high triglyceride levels.
On March 28, Amarin disclosed it had completed a submission of its supplemental New Drug Application to the FDA, which has yet to set a timeline for its regulatory review.
Jefferies analyst Michael Yee said the ADA update should help drive 2019 sales for Vascepa in a March 27 note to investors. Yee ballparked an FDA decision deadline for later this year or early 2020.
Yee noted that Vascepa's prescription growth rate has been in the double digits for at least the last two quarters. While Amarin projects $350 million in 2019 sales for Vascepa, Jefferies expects sales to surpass that figure.