Amarin said Thursday after the market close that it was notified by the FDA of the agency's intention to hold an Adcom meeting for its sNDA that seeks a label expansion for Vascepa, its fish oil pill.
Vascepa was initially approved in July 2012 as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, or very high triglycerides.
The label expansion Amarin is seeking is based on data from a Phase 3 trial dubbed REDUCE-IT, which evaluated a Vascepa 4g/day dose on its ability to reduce cardiovascular events in high-risk patients with hypertriglyceridemia who are on statin therapy.
Following the receipt of the sNDA, the FDA accepted the application May 29, granted it Priority Review status and set a PDUFA date of Sept. 28.
The FDA said the earliest date on which it can hold an Adcom meeting is Nov. 14, citing scheduling constraints.
Although the FDA has not notified the company of a PDUFA date extension, Amarin said it expects a delay. Assuming a three-month extension, the new PDUFA date could be in late December, the company said.
Amarin said the Adcom meeting is likely to present an opportunity to highlight its REDUCE-IT data.
"We plan to continue to work collaboratively with the FDA on the pending REDUCE-IT sNDA while we prepare for a robust launch of REDUCE-IT data assuming approval of Vascepa before the end of 2019 for a cardiovascular risk reduction indication based on REDUCE-IT," CEO John Thero said in a statement.
Why It's Important
The cardiovascular indication is likely to propel the pill to blockbuster status.
If the label expansion comes through by the timeline indicated by the company, Amarin could reap a rich financial reward.
Peak sales for the new indication could be in the order of $2 billion to $3 billion, Fierce Pharma reported, citing Jefferies analyst Michael Yee.
Amarin shares were down 16.51% at $14.87 at the time of publication Friday.
The Daily Biotech Pulse: Vascepa Delay Sends Amarin Reeling, Eidos Jumps On Buyout Offer, Nektar's Bitter Q2
DBV Resubmits Regulatory Application For Peanut Allergy Drug, Stock Rallies
See more from Benzinga
- The Daily Biotech Pulse: Vascepa Delay Sends Amarin Reeling, Eidos Jumps On Buyout Offer, Nektar's Bitter Q2
- The Daily Biotech Pulse: Roche-Spark Deal Faces Further Delay, Bayer's Prostate Cancer Drug Passes FDA Muster
- The Week Ahead In Biotech: Pending Clinical Readouts, Earnings Dominate
© 2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.