FDA Rejects Vascepa (Icosapent Ethyl) Trial Design
Company plans to appeal decision (January 21)
In response to a request from Amarin Corporation to reconsider its October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement, the FDA’s Division of Metabolism and Endocrinology Products (DMEP) has notified Amarin that the DMEP “does not plan to re-instate the ANCHOR SPA agreement.”
In its communication to Amarin, the DMEP stated that information submitted by Amarin supports testing the hypothesis that Vascepa (icosapent ethyl) 4 g/day versus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels. This hypothesis is being studied in the REDUCE-IT cardiovascular outcomes study.
However, the DMEP reiterated its position expressed at the October 2013 Vascepa advisory committee meeting that currently available data from studies of other therapies do not support the use of drug-induced reductions in serum triglycerides as a basis for approval of an indication that the DMEP views as ostensibly and impliedly an indication to reduce the risk of cardiovascular disease.
Amarin plans to appeal the DMEP decision to the FDA’s Director of the Office of Drug Evaluation II, the next level under FDA dispute resolution guidance.
Vascepa (icosapent ethyl) is an EPA omega-3 prescription product in a 1-gram capsule. It is currently approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (= 500 mg/dL) hypertriglyceridemia.
Source: Amarin Corp.; January 21, 2014.