Current Status of Vascepa Priority Review Request
No public records show an active or pending priority review request for Vascepa (icosapent ethyl) from the FDA as of the latest available data. Vascepa, approved in 2012 for triglyceride reduction and in 2020 for cardiovascular risk reduction via the REDUCE-IT trial, has not had a priority review designation for new indications or supplements in recent filings. The last major FDA action was the 2020 approval, which used standard review timelines.[1]
What Was the Last Vascepa FDA Submission?
Amarin submitted a supplemental New Drug Application (sNDA) in 2021 for Vascepa's use in patients with elevated triglycerides on statins, but it received standard review, not priority. This was approved in early 2022 without expedited status. No subsequent priority requests appear in FDA databases or Amarin's disclosures.[2][3]
Why Might Priority Review Apply to Vascepa?
Priority review shortens FDA review from 10 to 6 months for drugs addressing unmet needs with potential for significant improvement over existing therapies. Vascepa could qualify for new formulations, combinations, or expanded indications (e.g., broader CV prevention), but Amarin has focused on label expansions and patent protections rather than new priority filings.[1]
When Does Vascepa's Patent Protection End?
Key patents for Vascepa's CV indication expire in 2035-2039, with some facing challenges from generics like Hikma and Dr. Reddy's. No priority review ties directly to these; instead, Amarin is litigating to block ANDA approvals until at least 2030.[4]DrugPatentWatch.com
Are There Pending Studies or Labels Affecting Review?
Ongoing trials like EVAPORATE (plaque regression) and LODESTAR support label tweaks, but none have triggered priority review. Patients or investors tracking this should monitor Amarin's SEC filings for updates on any new submissions.[2]
[1]: FDA.gov - Vascepa Label and Approval History
[2]: Amarin Investor Relations - Pipeline Updates
[3]: FDA.gov - Novel Drug Approvals 2022
[4]: DrugPatentWatch.com - Vascepa Patent Expiration