Esperion confirms FDA acceptance of two NDAs for regulatory review
The NDAs are for oral therapies developed as medication for patients with raised LDL-C who require additional LDL-C lowering Esperion has recently announced that the U.S. Food and Drug Administration has officially accepted both bempedoic acid & bempedoic acid/ezetimibe combination tablet New Drug Applications for filing as well as regulatory review. Apparently, the bempedoic acid and bempedoic acid-ezetimibe combination tablet have been developed as affordable, suitable, once-daily, complementary, oral therapies for the medication of patients with raised low-density lipoprotein cholesterol or LDL-C who require additional lowering of LDL-C in spite of using presently accessible therapies. Sources mentioned that the Prescription Drug User Fee Act (PDUFA) goal date is set for 21 February 2020 for the completion of the NDA review of bempedoic acid. The PDUFA goal date for completing the NDA review of bempedoic acid/ezetimibe combination tablet is set for 26 February 2020. Chief Executive Officer and President of Esperion, Tim M. Mayleben, confirmed that both New Drug Applications have been accepted for filing by the US FDA. Mayleben said that the acceptances for regulatory review of these therapies confirm the superior-quality submissions and outstanding effort of the company’s Lipid Management Team, bringing the acid-based therapies of oral bempedoic further close to the patients and physicians who will benefit from them. Seemingly, the worldwide LDL-C Phase 3 Lowering Program of Esperion has been undertaken to support EMA and FDA Submissions. The company completed its worldwide, pivotal, Phase 3 clinical development program as well as unveiled positive cumulative results previous year in October. The program evaluated the consistency, safety and tolerability, complementary LDL-C-lowering efficiency of bempedoic acid/ezetimibe combination tablet and bempedoic acid in patients with ASCVD or who are at high risk for ASCVD. Sources further mentioned that bempedoic acid/ezetimibe combination tablet and bempedoic acid are new medication applications are under supervisory review by FDA. The marketing authorization applications for these product applicants are also under regulatory review by European Medicines Agency. Source Credit: https://www.nasdaq.com/press-release/esperion-announces-us-fda-acceptance-of-new-drug-applications-ndas-for-both-bempedoic-acid-and-the-20190505-00013 https://investor.esperion.com/news-releases/news-release-details/esperion-announces-us-fda-acceptance-new-drug-applications-ndas