Esperion announced that the company has successfully completed important and key global marketing applications including the submission of two new drug applications, or NDAs, for bempedoic acid and the bempedoic acid / ezetimibe combination tablet to the FDA. Bempedoic acid and the bempedoic acid / ezetimibe combination tablet are being developed as complementary, cost-effective and once-daily oral therapies for the treatment of patients with elevated low-density lipoprotein cholesterol, or LDL-C, who need additional LDL-C lowering despite the use of currently accessible therapies. Based on Esperion’s bempedoic acid submission date of February 20 as well as the bempedoic acid / ezetimibe combination tablet submission date of February 26, the company expects to receive notification from FDA on whether the submissions were filed for review in May. Esperion also announced that the European Medicines Agency, or EMA, has completed formal validation of Esperion’s two marketing authorization applications, or MAAs, and officially started the review procedure for both bempedoic acid and the bempedoic acid / ezetimibe combination tablet. The MAAs for bempedoic acid and the bempedoic acid / ezetimibe combination tablet were submitted to the EMA on February 11. The MAAs for bempedoic acid and the bempedoic acid / ezetimibe combination tablet are being reviewed via the centralised procedure with an opinion of the Committee for Medicinal Products for Human Use, or CHMP, expected by Day 210. After the adoption of a CHMP opinion, a final decision regarding the MAA is carried out by the European Commission.
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