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Can we request a priority review for the vascepa application?

See the DrugPatentWatch profile for vascepa

The Vascepa (icosapent ethyl) application is an investigational new drug (IND) submitted by Amarin Pharma for the treatment of cardiovascular disease. The application is currently under review by the United States Food and Drug Administration (FDA).

Regarding the possibility of requesting a priority review for the Vascepa application, the FDA has a process in place for expedited review of certain applications. According to the FDA's website, priority review is granted to applications that, if approved, would be "likely to have a significant impact on public health" [1]. The FDA also considers applications for priority review that treat serious or life-threatening diseases, or those that provide a significant therapeutic advantage over existing treatments [2].

However, it is important to note that the FDA's decision to grant priority review is not guaranteed and is typically granted on a case-by-case basis. The FDA considers various factors, including the strength of the scientific evidence supporting the application, the potential benefits of the treatment, and the potential risks associated with the treatment [3].

DrugPatentWatch.com, a leading source for pharmaceutical patent information, reports that Amarin Pharma has filed several patents related to Vascepa, including patents for the use of icosapent ethyl in the treatment of cardiovascular disease [4]. While the patent status of Vascepa is not directly related to the priority review process, it may be relevant to the FDA's consideration of the application.

In conclusion, while it is possible to request a priority review for the Vascepa application, the FDA's decision to grant priority review is not guaranteed and is typically granted on a case-by-case basis. The FDA considers various factors, including the strength of the scientific evidence supporting the application, the potential benefits of the treatment, and the potential risks associated with the treatment.

Sources:

[1] FDA. (n.d.). Priority Review. Retrieved from <https://www.fda.gov/priority-review>

[2] FDA. (n.d.). Priority Review. Retrieved from <https://www.fda.gov/priority-review>

[3] FDA. (n.d.). Priority Review. Retrieved from <https://www.fda.gov/priority-review>

[4] DrugPatentWatch.com. (n.d.). Vascepa (Icosapent Ethyl) Patents. Retrieved from <https://www.drugpatentwatch.com/patent-search/vascepa-icosapent-ethyl-patents>


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