The US Food and Drug Administration (FDA) advisory committee unanimously recommended expanding the indication for the Amarin "Vasp" corporation (icospent ethyl).
Amarin announced on Friday that the FDA's Endocrine and Metabolic Advisory Board (EMDAK) recommended 16 votes to "zero" to approve Vasepa to reduce the risk of cardiovascular events in patients at high risk for cardiovascular disease. I did it.
This is based on the results of a clinical trial of cardiovascular disease REDUSH-IT.
Order-IT has been administered for a total of 7 years to 8179 patients. When combined with statin therapy, Vasepa reduces the risk of heart attack, stroke and other cardiovascular events by about 25% compared to placebo.
The FDA is not required to comply with advisory board comments. Amarin plans to work with the authorities to complete the review of this appropriate labeling application to reflect the results of the REDUCE-IT study. Vasefa was licensed in the United States to lower triglyceride levels in 2012.
Cardiovascular disease is a leading cause of death for both men and women in the United States and is estimated to incur large direct and indirect costs of $ 500 billion annually. According to the company, independent drug price monitoring agencies have concluded that Vasepa is economical even by the most stringent standards.
"Today we have made significant progress in helping millions of patients at risk for cardiovascular disease despite standard statin therapy," said Tony T., chief executive of Amarin. It will be the first treatment to reduce the incident. "
"We look forward to discussing the expansion of the label on the assumption that approval will be given on or before December 28, which should be completed."
Market analysts predict Vasepa will be a game changer in the cardiovascular market.
< 저작권자 © 의약뉴스 무단전재 및 재배포금지 >