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Esperion Aligns with U.S. Food and Drug Administration to Initiate Phase 3 Clinical Trials of Bempedoic Acid in Pediatric Heterozygous and Homozygous Familial Hypercholesterolemia
– Confirms Sufficient Data to Complete Phase 2 Clinical Study Enrollment and Advance to Phase 3 Studies in Both Heterozygous and Homozygous Familial Hypercholesterolemia – – Establishes Pediatric Path Forward to Start and Complete Phase 3 Trial and Secure Additional Six-Month Patent Extension Through June 2031 – ANN ARBOR, Mich., March 20, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that following meetings with the U.S. Food and Drug Administration (FDA), it has gained align
About this update from Esperion Therapeutics, Inc.
[{"type":"image","alt":"Esperion Therapeutics, Inc.","displaySize":"","headline":null,"caption":"Esperion Therapeutics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":94,"url":"https://media.zenfs.com/en/globenewswire.com/4890074d6b0f0d0a38002f9d11a84e21"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/l5dS5p4arlgcAzQpBUpJMQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzMjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/4890074d6b0f0d0a38002f9d11a84e21","width":300,"height":94}},"lazy":false},{"type":"text","content":"– Confirms Sufficient Data to Complete Phase 2 Clinical Study Enrollment and Advance to Phase 3 Studies in Both Heterozygous and Homozygous Familial Hypercholesterolemia –","length":171,"tagName":"p"},{"type":"text","content":"– Establishes Pediatric Path Forward to Start and Complete Phase 3 Trial and Secure Additional Six-Month Patent Extension Through June 2031 –","length":141,"tagName":"p"},{"type":"text","content":"ANN ARBOR, Mich., March 20, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that following meetings with the U.S. Food and Drug Administration (FDA), it has gained alignment on a regulatory path forward for initiating Phase 3 studies of bempedoic acid alone and in combination with ezetimibe in pediatric patients with heterozygous and homozygous familial hypercholesterolemia (HeFH and HoFH, respectively). Based on these discussions with the FDA, the Company plans to initiate Phase 3 clinical studies this year. The FDA previously granted orphan drug designation for bempedoic acid in HoFH indication.","length":621,"tagName":"p"},{"type":"text","content":"“We are delighted to further advance the development of bempedoic acid for children with familial hypercholesterolemia (FH) and are pleased the FDA has indicated that we have adequate data to proceed into Phase 3 clinical trials,” stated Sheldon Koenig, President and CEO of Esperion. “In addition, this alignment supports our commitment to broaden the reach of our bempedoic acid products as part of our lifecycle management plan, providing the opportunity to extend our patent protection for an additional six months for these important therapies,” added Sheldon Koenig.","length":572,"tagName":"p"},{"type":"text","content":"About CLEAR Path 2 and CLEAR Path 3 StudiesCLEAR Path 2 (in children with HeFH) and CLEAR Path 3 ...