Esperion announced that the U.S. Food and Drug Administration has accepted both New Drug Applications for bempedoic acid and the bempedoic acid/ezetimibe combination tablet for filing and regulatory review. Bempedoic acid and the bempedoic acid/ezetimibe combination tablet were developed to be complementary, cost-effective, convenient, once-daily, oral therapies for the treatment of patients with elevated low-density lipoprotein cholesterol who need additional LDL-C lowering despite the use of currently accessible therapies. The PDUFA goal date for the completion of the bempedoic acid NDA review is set for February 21, 2020, and the PDUFA goal date for completion of the bempedoic acid/ezetimibe combination tablet NDA review is set for February 26, 2020. The FDA has communicated that there is no current plan to hold an advisory committee meeting to discuss the applications.
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