2024-03-25 07:02:33 ET
DENVER, Colo., Mar 25, 2024 ( 247marketnews.com )- Esperion (NASDAQ: ESPR ) reported, after Friday’s market close, that the FDA approved broad new label expansions for NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. The enhanced labels also support the use of NEXLETOL and NEXLIZET either alone or in combination with statins, including new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients, expanding the U.S. treatable population to about 70 million patients.
“We are pleased to receive approval for our highly anticipated label expansions in the U.S., which will enable more than 70 million patients to now be eligible for NEXLETOL and NEXLIZET,” said Sheldon Koenig, President and CEO, Esperion. “Importantly, these approvals expand the accessibility of our highly effective drugs to primary prevention patients, or to those who are at high risk of having a cardiovascular event, but who have not yet had one. These approvals also eliminate the statin use requirement, allowing patients to take NEXLETOL or NEXLIZET either with or without a statin, which significantly reduces previously existing prescribing limitations. We are confident these approvals position NEXLETOL and NEXLIZET as the non-statins of first choice within the cardiovascular risk reduction treatment paradigm.”
“We are thrilled with these significantly expanded labels and look forward to being able to now reach millions more patients with our life-saving drugs. In anticipation of these approvals, we have significantly ramped up our sales force, developed a powerful suite of new promotional materials, created a bold new consumer campaign, enhanced our patient support programs, and continued working with payers to ensure improved patient access.”
“NEXLETOL and NEXLIZET are once-daily, accessible, oral medications that reduce LDL-C and cardiovascular risk, but without the side effects most common to statins. NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients. We believe this significantly differentiated profile is a game changer for patients and healthcare providers alike and that we expect sales to meaningfully inflect as a result. I want to thank the entire Esperion team for its unwavering commitment to patients and to getting us to this stage. I have the utmost confidence in our future success.”
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FDA Approves Broad New Labels for Esperion’s NEXLETOL and NEXLIZET