ANN ARBOR—Esperion Therapeutics Inc. has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a “positive opinion” for both its bempedoic acid and its benpedoic acid-ezetimibe tablets to treat high cholesterol and other risky conditions involving lipids in the bloodstream.
Company officials said the committee “found there were no substantive issues that needed to be discussed with the CHMP at the time of the vote.” The most common side effects of the drugs were found to be high uric acid levels and constipation.
Both tablets are intended to treat high cholesterol and other blood disorders in people who have difficulty tolerating today’s statin drugs at effective doses. They can also be administered in combination with statins to reduce LDL-C, the so-called bad cholesterol.
The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit. The European Commission will review the CHMP opinion and is expected to adopt a final decision in April 2020. The decision will be applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein.
The opinion is supported by data from a Phase 3 clinical trial on more than 300 patients. Results of the study have been published in The European Journal of Preventative Cardiology.
Daiichi Sankyo Europe has licensed exclusive commercialization rights to bempedoic acid and the bempedoic acid-ezetimibe fixed dose combination tablets in the European Economic Area and Switzerland from Esperion. Upon approval, Daiichi Sankyo Europe intends to make the tablets available to physicians and their patients in these geographies that need treatment for hypercholesterolemia and mixed dyslipidemia.
“Today’s positive recommendations from the CHMP brings bempedoic acid and the bempedoic acid-ezetimibe fixed dose combination tablets one step closer to helping the millions of patients in the European Economic Area who have not achieved their LDL-C goals despite currently available medicines, including those who are statin intolerant,” said Tim M. Mayleben, president and CEO of Esperion. “We look forward to continuing to work with the EMA to complete the procedure for these two MAAs by next quarter.”
The tablets are also under regulatory review by the U.S. Food and Drug Administration.
Bempedoic acid has also been found to reduce high sensitivity C-reactive protein (hsCRP), a key marker of inflammation associated with cardiovascular disease. Completed Phase 3 studies conducted in more than 4,000 patients, with over 2,600 patients treated with bempedoic acid, demonstrated up to 18 percent placebo corrected LDL-C lowering when used with moderate- and high-intensity statins and 21 to 28 percent placebo corrected LDL-C lowering when used with low dose or no background statin. Phase 3 results also show bempedoic acid reduced hsCRP 19 to 31 percent. Pooled phase 3 data highlighted that bempedoic acid reduced hemoglobin A1c (HbA1c) by 0.19 percent versus placebo in patients with diabetes at 12 weeks.
More at www.esperion.com.
