Amarin may still be waiting for the FDA to include new risk-reduction info to Vascepa's label, but in the meantime, it's getting prepared. The company is testing a pilot TV and digital ad program in select markets for the triglyceride fighter. The new effort includes a tweaked TV ad from a campaign last year, which now includes a warning about fish oil supplements.
The company intends to apply what it learns from the pilot programs to a broader advertising campaign if it later this year scores its expected FDA approval to expand the Vascepa label for cardiovascular risk reduction, an Amarin spokeswoman said.
Vascepa is awaiting an FDA decision after hitting a speedbump last week, when the agency called for an advisory committee meeting review on Nov. 14. The surprise announcement came after Amarin had already received a priority review designation in May and an FDA target decision date of Sept. 28.
Amarin obviously won’t meet that original timeline with the panel meeting in November, but the company is continuing down its indication launch path, hiring sales reps and preparing for a big rollout despite the delay.
The latest Vascepa TV ad comes on the heels of a recent study that largely dismisses widespread consumer thinking—and spending—on the value of supplements to improve health. A study and editorial in the Annals of Internal Medicine concluded supplements remain in the same “foggy conditions” of no definitive benefits, with the article adding that “until these conditions clear, it would be reasonable to hold off on any supplement or diet modification in all guidelines and recommendations."
To create the ad, Amarin took the TV spot it launched last summer and changed portions to add the fish oil supplement warning. The new ad recommends diet and exercise in the fight to manage very high triglycerides, and then a voiceover says this: “But if you’re taking fish oil supplements, you should know they are not FDA approved. They may have saturated fat and may even raise bad cholesterol.”
“Through our DTC, we are continuing to educate and raise awareness about Vascepa as well as educate people on the fact that supplements are not FDA-approved or intended to treat medical conditions. Many people are misinformed or unaware of this and need to know that there is an FDA- approved and efficacious prescription medication that can help to reduce their triglycerides," the spokeswoman said by email.
Vascepa got off to a blazing start with landmark outcomes results, a recommendation in the American Diabetes Association’s 2019 guidelines, and a $400 million stock offering in the past year. Last week’s call for an AdCom may have changed the timing but it didn’t seem to dampen enthusiasm. Jefferies analyst Michael Yee said in a note that he and his fellow analysts still expect the FDA to approve Vascepa “given clearly significant (and transformative) evidence of benefit for an unmet need.” With an FDA-approved label expansion, peak sales could reach $2 billion to $3 billion, he said.