Vascepa Is Safe and Should Be Approved by End of Year, Amarin CEO Says (Video)
Posted on August 29, 2019 by Medtech[y] Staff
Amarin CEO, John Thero, was on Bloomberg yesterday and reiterated that a successful panel with the FDA could lead to the expanded approval for Vascepa and increase the amount of patients who can benefit from the drug.
The advisory committee has been tentatively scheduled for November and will review the company's supplemental new drug application to expand Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study.
The CEO noted that an advisory committee is "pretty common" and that he sees it as a "great forum" to discuss Vascepa.
During the interview, Thero also stated that the company has already started to expand their salesforce ahead of the "robust" launch.
With the meeting tentatively scheduled for November 14, the company does not expect the FDA to take action on the supplemental new drug application by the previously announced September 28 PDUFA goal date.
In regards to pricing, Thero stated that "patients who have insurance coverage can get this drug for about $3 a day."
Amarin will provide an update after appropriately definitive information is available related to a new PDUFA date.