Esperion Therapeutics announced Monday that it received positive feedback from the FDA regarding its clinical development programme for the experimental low-density lipoprotein cholesterol (LDL-C) lowering therapy bempedoic acid, sending shares in the drugmaker up as much as 52 percent. Specifically, the agency concluded that the company's LDL-C lowering programme is sufficient to support approval of the treatment.
Esperion indicated that it plans to submit a filing for bempedoic acid by the first half of 2019 based on the completion of its global pivotal Phase III programme. The drugmaker said that its proposed product label will include specific language backing the use of the drug as an adjunct to maximally tolerated statin therapy in patients with hypercholesterolemia, specifically those at high risk for cardiovascular disease (CVD) due to atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolaemia who require additional LDL-C lowering.
The company explained that the Phase III programme, which was initiated in January 2016, includes a global 52-week long-term safety and tolerability study in patients with hypercholesterolaemia at high CVD risk whose LDL-C is not adequately controlled despite current lipid-modifying therapies. Meanwhile, an open-label extension trial of this study was started last month.
Esperion CEO Tim Mayleben commented "we are very pleased to have achieved clarity from FDA regarding Esperion’s LDL-C lowering development programme." The executive added "we remain focused on completing the global pivotal Phase III programme for bempedoic acid and reporting top-line results from our long-term safety and tolerability study by Q2 2018 and top-line results from our ongoing Phase 3 LDL-C lowering efficacy studies by mid-2018."
Commenting on the news, RBC Capital Markets analyst Michael Yee, who said he was "surprised" by the FDA feedback, remarked "indeed, the caveat and risk is FDA can say anything but ultimately a decision is based on the totality of risk/benefit after all the Phase III data including safety is in hand and the regulatory environment at that time," continuing "nonetheless, this is a fundamental big positive and a big de-risking event."
For related analysis, read Spotlight On: Anti-PCSK9 players not the only ones with a lot on the line at ACC.
To read more Top Story articles, click here.