Posted by Michael Wonder on 31 Jan 2021
Amarin receives positive CHMP opinion for icosapent ethyl for cardiovascular risk reduction
29 January 2021 - Positive opinion is based on extensive clinical study results, including results of the REDUCE-IT cardiovascular outcomes trial.
Amarin Corporation today announced that in response to Amarin’s marketing authorisation application submission, the CCHMP of the EMA has adopted a positive opinion, recommending that a marketing authorisation be granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name Vazkepa.
