The Advisory Committee voted against recommending ANCHOR approval by a margin of nine to two. Joseph S. Zakrzewski, CEO said, ‘It's frustrating to have a number of panel members express that the company did everything that’s been asked of it for negotiating SPAs yet still not receive a positive vote for approval’.
The company conducted a successful MARINE study, a successful ANCHOR study, successfully enrolled the REDUCE-IT trial to over 6,000 patients and has a product that everyone ultimately agreed was safe. The company still continues to believe that a fair read of all the available data including available outcome studies reflect positively on Vascepa, the ANCHOR indication and the anticipated results of the upcoming REDUCE-IT study.
The FDA is scheduled to make its decision on whether to approve the ANCHOR supplemental sNDA by December 20, 2013; that's the PDUFA date, the company’s goal date for the application.
Recommendations provided by the Advisory Committee will be considered by the FDA in its review but the FDA is not bound to follow them in determining whether they will approve an application. ‘Having said that, we do recognize, given today's panel, that this is an uphill battle’ said Mr. Zakrzewski.
As expected, based on the FDA’s briefing materials there was very robust discussion in the meeting surrounding the efficacy and safety of Vascepa and the desire for the improvement of cardiovascular outcomes in treating patients with mixed dyslipidemia, but it wasn’t enough to win the day.