Posted by Michael Wonder on 03 Feb 2020
Esperion announces positive CHMP opinion for the marketing authorisation application for bempedoic acid for the treatment of hypercholesterolaemia and mixed dyslipidaemia
31 January 2020 - Positive CHMP opinion is based on the completed pivotal Phase 3 LDL-cholesterol lowering program.
Esperion today announced that the CHMP of the EMA has adopted a positive opinion for the marketing authorisation application for the bempedoic acid tablet, recommending approval for the treatment of hypercholesterolaemia and mixed dyslipidaemia.
The positive CHMP opinion was achieved with no Oral Explanation as the Rapporteurs found there were no substantive issues that needed to be discussed with the CHMP at the time of the vote.
