05/29/2019 | Press release | Distributed by Public on 05/29/2019 09:12
Amarin said Wednesday that its sNDA for Vascepa capsules - icosapent ethyl capsules, or a fish oil pill - has been accepted by the FDA with a Priority Review designation.
FDA grants Priority Review Designation to drugs with the potential to offer significant improvements in effectiveness and safety of treating serious conditions compared to the current standard-of-care.
Vascepa is poised to become the first drug indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but persistently elevated triglycerides - an important indicator for cardiovascular disease.
Millions of people are estimated to be affected by this serious health challenge.
With the FDA's decision to accord Priority Review designation, the PDUFA date is set for Sept. 28, four months sooner than expected.
'We believe the unprecedented REDUCE-IT results position Amarin to lead a transformative change in clinical practice for preventative treatment of cardiovascular disease, the leading cause of death for both men and women in the United States,' Amarin CEO John Thero said in a statement.
Amarin said it is expediting plans to significantly expand the promotion of Vascepa based on the development.
Amarin shares were rallying by 13.93 percent to $19.38 at the time of publication Wednesday.