FDA Delays Amarin ANCHOR SPA sNDA Decision
The biopharmaceutical company Amarin Corporation, announced this week that the Division of Metabolism and Endocrinology Products (DMEP), a sub department of the FDA, notified the company that their decision to reconsider the ANCHOR clinical trial Special Protocol Assessment (SPA) had been delayed. The company entered an application request for reconsideration of the DMEP’s October 2013 decision to rescind the agreement.
In previous communications, the FDA notified Amarin that a decision would be presented to them by January 15, 2014. The initial date has passed and the DMEP did not disclose a definitive date for which they plan to make a decision available to Amarin.
Amarin specializes in developing and commercializing therapies for cardiovascular conditions. The FDA has already approved the Vascepa drug associated with the trial as an adjunct to diet in order to reduce the triglyceride levels of patients with severe hypertriglyceridemia. According to the ANCHOR SPA Supplemental New Drug Application, Vascepa has been presented to the FDA as an adjunct to diet and exercise for patients already on statin therapy with mixed dyslipidemia, whose triglyceride levels are between 200 and 499 mg/dL.
The Vascepa drug is sold in 1 gram capsules and contains a highly pure-EPA omega3 concentrated prescription. As of yet, there has been no study that addresses the effect Vascepa has on the risk of developing or aggravating pancreatitis in patients or cardiovascular mortality and morbidity, for patients with severe hypertriglyceridemia. Patients who have experienced adverse effects to the drug or any of its components, fish or shellfish have to be monitored cautiously while taking the medication as it could produce an anaphylactic reaction.