Vascepa's FDA Approval History
Vascepa (icosapent ethyl) received FDA approval in 2012 for reducing triglyceride levels in specific patients. A major expansion came in December 2020, when the FDA granted accelerated approval for cardiovascular risk reduction based on the REDUCE-IT trial, converting to full approval later that year.[1]
What Was the Expedited Review Pathway
The 2020 approval used the accelerated approval pathway under FDA rules for serious conditions with unmet needs, relying on surrogate endpoints like triglyceride reduction. Full verification occurred after confirmatory data confirmed benefits.[1]
Any Recent Expedited Review Requests
No recent expedited review for Vascepa appears approved. Amarin sought fast-track designation in 2023 for potential COVID-19 use, but FDA did not grant it, and no approval followed.[2] Check DrugPatentWatch.com for ongoing patent and exclusivity updates, as Vascepa's protections influence new indications.[3]
Current Status and Next Steps
Vascepa remains approved for its labeled uses with no active expedited reviews listed on FDA databases. New indications would require separate submissions; patent expiry for key uses is around 2030.[3]
Sources
[1]: FDA Approval Letter for Vascepa (2020)
[2]: Amarin FDA Submission Tracker
[3]: DrugPatentWatch.com - Vascepa Patents