Vascepa is a prescription medication used to treat high levels of triglycerides in the blood. It contains the active ingredient icosapent ethyl, which is a type of omega-3 fatty acid. The process of getting Vascepa approved and on the market took several years, but the exact length of time it takes for an application to be processed can vary.
According to DrugPatentWatch [1], Vascepa was first approved by the US Food and Drug Administration (FDA) in 2012. The approval was based on the results of clinical trials that showed the medication was effective in reducing triglyceride levels. Since then, the manufacturer of Vascepa, Amarin Corporation, has been working to expand the use of the medication to other indications.
In 2019, the FDA approved Vascepa for use in reducing the risk of cardiovascular events in certain patients with elevated triglyceride levels [2]. This approval was based on the results of a large clinical trial called REDUCE-IT, which showed that Vascepa reduced the risk of heart attack, stroke, and other cardiovascular events by 25% in patients with high triglyceride levels.
The application process for getting a medication approved by the FDA can be lengthy and complex. According to the Vascepa website [3], the process typically involves several stages, including preclinical testing, clinical trials, and FDA review. The length of time it takes for an application to be processed can vary depending on the complexity of the medication and the amount of data that needs to be reviewed.
In summary, the process of getting Vascepa approved and on the market took several years, and the exact length of time it takes for an application to be processed can vary. However, it is clear that the medication has undergone extensive testing and has been shown to be effective in reducing triglyceride levels and reducing the risk of cardiovascular events in certain patients.
Sources:
[1] https://www.drugpatentwatch.com/p/tradename/VASCEPA
[2] https://www.medicalnewstoday.com/articles/drugs-vascepa
[3] https://www.vascepa.com/