A panel of experts advises FDA to give doctors more ability to write a fish oil derived drug.
The panel met to consider an additional indication for fish oil derived Vescepa. Vescepa is a clear 1mg softgel consisting of highly refined pure EPA.
To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)” (available at: https://clinicaltrials.gov/ct2/show/NCT01492361).
The Advisory Committee stated that the evidence was robust and consistent from the REDUCE-IT trial.
Icosapent ethyl 4 g/day resulted in significant reduction of major adverse CV events, including CV death and a range of prespecified CV endpoints, in statin-treated patients with controlled LDL-C (≤100 mg/dL), but elevated residual TG levels (≥135 mg/dL) and other CV risk factors. Icosapent ethyl 4 g/day was generally well tolerated, with the nature and type of AE findings consistent with long-term treatment options for CV event management
Experts conclude that the FDA should promptly approve reasoning the following,
Approval of icosapent ethyl for CV risk reduction would increase access to this therapy and thereby provide an opportunity to lower CV risk beyond what can be achieved with LDL-C lowering therapies alone. There are approximately 5 to 15 million people in the US who meet the REDUCE-IT inclusion criteria. Based on the REDUCE-IT results, if these patients were treated with icosapent ethyl, the number of primary endpoint events could be reduced by more than 150,000 to 450,000 per year (Bhatt 2019(c); Fan 2019). Such reduction in CV events not only reduces pain and suffering, it also increases productivity. Also, the costs of treating CV events are high, particularly when including rehabilitation for patients who experience debilitating CV events such as stroke. Icosapent ethyl is cost-effective and, therefore, has the potential to lower healthcare costs. New therapy adoption requires time and education; potentially helping even a fraction of at- Amarin Pharmaceuticals Ireland Limited Advisory Committee Briefing Document 14 November 2019 81 risk patients like those who participated in REDUCE-IT warrants prompt approval of a CV risk reduction indication for icosapent ethyl.