Amarin Corporation plc (NASDAQ: AMRN) shares were climbing to a 3-1/2 month high Tuesday after the FDA posted a briefing document ahead of an Adcom meeting on Amarin's fish oil capsule Vascepa that's scheduled for Thursday.
Vascepa, or icosapent ethyl, was previously approved in 2012 as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
The company is now seeking a label expansion to include cardiovascular risk reduction in an appropriate statin-treated patient population.
The sNDA was supported by the REDUCE-IT trial, a third Phase 3 study that evaluated the effect of 4g/day of Vascepa for preventing cardiovascular events in statin-treated patients with controlled LDL-C, but moderately elevated triglyceride levels and other cardiovascular risk factors.
Analyst: 'No Surprises'
FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which is set to discuss the company's Vascepa sNDA, said the REDUCE-IT trial provides robust and consistent evidence for cardiovascular risk reduction.
"Events such as serious bleeding and serious or adjudicated cases of atrial fibrillation/flutter occurred at relatively low rates; in context of observed benefits, we believe these imbalances can be effectively communicated to clinicians and patients," FDA staffers said.
Cantor Fitzgerald analyst Louise Chen said in a Tuesday note that the FDA's questions and comments "were in line with Street expectations and there were no surprises."
While noting that bears are concerned regarding the potential impact of statin-mineral oil interactions on REDUCE-IT results, Chen said FDA staffers seem to be believe the concern is overdone.
"The estimated hazard ratio per unit LDL-C value suggests that the [~12%] difference in LDL-C between the Placebo and AMR101 arms from baseline would increase the risk of cardiovascular outcomes by only 3.1% in the placebo arm of the REDUCE-IT trial," the briefing document said.
The advisory committee is set to issue its verdict on Thursday, while the PDUFA goal date is estimated to be Dec. 28.
The FDA, though it will consider the verdict of the Adcom panel, is not bound to follow it.
Following the Adcom verdict, the next key catalyst is the IP debate, said Cantor Fitzgerald's Chen.
"We think the peak sales potential of Vascepa is underappreciated. Therefore, upward earnings revisions to levels not reflected in FactSet consensus expectations should drive AMRN shares higher," the analyst said.
Amarin shares were trading 22.09% higher at $20.64 at the time of publication.