Hearts & Minds Blog
The Bempedoic Acid / Ezetimibe Combo Pill: Our Leading Complementary, Non-statin, Oral TherapyJune 26, 2017
This week we announced a major milestone: the U.S. Food and Drug Administration (FDA) confirmed the regulatory pathway to approval for an LDL-cholesterol lowering indication for our once-daily, oral combination of bempedoic acid 180 mg and ezetimibe 10 mg. The complementary, non-statin combo pill lowers LDL–cholesterol (LDL-C) by almost 50%, while significantly reducing a key marker of inflammation associated with cardiovascular disease known as high-sensitivity C-reactive protein (hsCRP), while potentially lowering the occurrence of muscle-related side effects.
As you may recall, this follows our March announcement that the FDA confirmed the regulatory pathway to approval for an LDL-C lowering indication for bempedoic acid. Coupled with this recent positive news regarding the bempedoic acid / ezetimibe combo pill’s pathway to approval, we now have two convenient, cost-effective, complementary, non-statin oral therapies in Phase 3 development for the treatment of patients still living with elevated LDL-C despite taking maximally tolerated statin therapy.
We are particularly excited about our bempedoic acid / ezetimibe combo program because of the complementarity of the products’ mechanisms of action. Here’s how the combination works: bempedoic acid inhibits the liver’s ability to synthesize cholesterol, while ezetimibe blocks absorption of cholesterol from the gut. Ultimately, these result in the upregulation of LDL receptors, which leads to lower levels of LDL-C. This combo pill has been shown to be safe and well-tolerated in patients studied to date.
Additionally, we believe the combo pill will be especially attractive to payers who are looking for highly-effective yet low-cost LDL-cholesterol lowering drugs, especially once-daily, oral therapies, that can be cost-effectively and conveniently added-on to generic maximally tolerated oral statins and ezetimibe. We expect that both the combo and bempedoic acid will be priced similarly to the historical prices of branded statins and ezetimibe. With ezetimibe and statins now generic, there is an opportunity for the combo and bempedoic acid to be THE preferred options for patients, physicians and payers.
So, what’s next for our team as we continue to advance our bempedoic acid / ezetimibe combo program? As agreed to with FDA, we plan to initiate a single Phase 3 bridging study evaluating the safety and efficacy of the combo, which we’ll use to support an application for an LDL-C lowering indication in the U.S. and Europe. Concurrently, we’ll continue to advance our ongoing Phase 3 program for bempedoic acid, and expect to submit a New Drug Application (NDA) to the FDA and Marketing Authorization Application (MAA) for an LDL-C lowering indication, consistent with the European Medicines Agency’s guideline, in tandem with filing the NDA and MAA submissions for bempedoic acid.
It’s been an exciting year for Esperion and we are energized by the FDA’s confirmation of the road ahead. This recent news is not only a major milestone for our team of lipid management experts but, as we advance these two distinct programs, we believe the bempedoic acid / ezetimibe combo is the right drug, at the right time, with the right price to truly appeal to patients, physicians and payers. These developments bring us a step closer to providing patients, physicians and payers with much-needed oral options to conveniently and cost-effectively lower elevated LDL-C.