Esperion Announces FDA Confirmation Regarding Regulatory Pathway to Approval for an LDL-C Lowering Indication for Bempedoic Acid
- Global Pivotal Phase 3 Program Design Can Support Approval for an LDL-C Lowering Indication -
- Proposed LDL-C Lowering Indication Will Include Patients with High CVD Risk, Specifically Those with ASCVD and/or HeFH -
- On Track to Submit NDA for an LDL-C Lowering Indication by 1H 2019 -
- Conference Call and Webcast on Monday, March 20, 2017 at 8:00 a.m. Eastern Time -
ANN ARBOR, Mich., March 20, 2017 -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the U.S. Food and Drug Administration (FDA) recently confirmed that Esperion’s LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid.
- Published: 20 March 2017
- Written by Editor