There has been clinical research evaluating the potential of VASCEPA® (icosapent ethyl) as a treatment for patients with persistent cardiovascular disease. The double-blind, placebo-controlled EVAPORATE trial enrolled 80 patients. For nine months, the patients underwent an interim scan and a final scan at 18 months. Amarin Corporation plc (NASDAQ:AMRN) says it supports the new data collected from the trial.
A significant reduction in the primary endpoint was observed from a comparison of the change in LAP volume between icosapent ethyl and placebo at 18 months. The same happened with the secondary endpoints, and the only one not achieved was the difference between groups in multivariable modeling, which was dense in calcium. The data has since been presented at ESC Congress 2020 during the annual meeting of the European Society of Cardiology (ESC).
The Need for Advanced Research on Cardiovascular Disease
Cardiovascular disease is devastating and comes with detrimental effects on patients and their caregivers as well as the healthcare systems. Statistics have revealed more than 600,000 new and 200,000 recurrent events of heart attacks annually in the US.
However, as the disease continues to impact and challenge thousands of people worldwide, Amarin’s chief medical officer Craig Granowitz has outlined the need for advanced research on the disease. He says this will help increase the understanding of how to deal with it and how to avert it.
‘’… Data presented at ESC Congress 2020 provides additional support for potential ways in which VASCEPA can help to alleviate the burden of the worldwide public health crisis that is cardiovascular disease,” the company’s senior VP added.
The Loss of Vascepa Patent Appeal
Despite being in full support of the date regarding clinical research for VASCEPA, Amarin has suffered another setback with its Vascepa’s blockbuster. While the FDA had already approved label expansion, a district judge struck out the ruling that had given the company patent protection of its purified fatty acid pill against generic challengers.
Nonetheless, the drug makers say it is not letting this matter and looking for other legal options. The plan is to file for an “en banc” session before a 12-judge appeals panel.