Press "Enter" to skip to content

Amarin To Get FDA Approval For Fish Oil Drug Benefitting For Cardiovascular Issues

Clinical information of fish-based oil that is drug by Amarin Corporation PLC verified the drug’s capability to lessen the relative danger of heart conditions. This heart condition includes a reduction in adverse cardiovascular events by 25% and a 20% reduction in cardiovascular death.

Recently, Ireland-based Amarin revealed the outcomes from “REDUCE-IT” trial at the 2018 Scientific Sessions of the AHA (American Heart Association) held in Chicago. The results showed that Vascepa (icosapent ethyl) is helpful in aiding cardiovascular patients. Amarin is said to be the fish oil-based drug that has “several robust demonstrations of effectiveness.” The presentation in Chicago enlarged the data which was previously released by the company in the last few months regarding the cardiovascular usefulness of Vascepa. In its information, Amarin said that the cardiovascular aid of Vascepa does not emerge to be considerably manipulated by triglyceride levels at the standard line, or as achieved at 1 Year. That indicates that there are methods at work in Vascepa that are self-regulating of triglyceride reduction, the company stated. Vascepa has previously been approved to heal patients with triglyceride levels more than 500 mg per deciliter (triple normal levels). Amarin said trial outcomes were robust in multiple subgroups, counting in patients without and with diabetes at the standard line. On the basis of the results of the “REDUCE-IT trial,” Amarin intends to submit a new drug application to the FDA (Food and Drug Administration) in early 2019.

Recently, the FDA was also in news for recalling another blood pressure medication due to cancer concerns. The U.S. FDA is recalling a blood pressure medication—Losartan—after discovering impurity that can cause cancer. The intended recall of Losartan potassium-hydrochlorothiazide by Sandoz Inc., a pharmaceutical company, is for 100 Mg/25 Mg tablets having the lot number JB8912. The affected product was circulated nationwide on and after October 8, 2018. In total, the recall includes less than 1% of the national Losartan drug products.

Be First to Comment

Leave a Reply

Your email address will not be published. Required fields are marked *