Esperion Therapeutics said that the FDA authorised Nexlizet (bempedoic acid/ezetimibe) as the first non-statin, LDL-cholesterol lowering combination medicine to be approved. The clearance comes shortly after the agency authorised the ATP citrate lyase inhibitor Nexletol (bempedoic acid).
According to Esperion, Nexlizet is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolaemia or established atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol. The company indicated that the oral, once-daily drug will be commercially available in the US in July.
The approval of Nexlizet is supported by results from a late-stage study, which showed that the combination medicine lowered LDL-cholesterol by a mean of 38% compared to placebo when added on to maximally tolerated statins. "I believe this one-of-a-kind combination medicine which has two complementary, non-statin medications can provide highly effective additional reductions in LDL-cholesterol when added to statin therapy," remarked Christie Ballantyne, chairman of Esperion's Phase III executive committee.
The company indicated that Nexlizet will be priced "at parity" with Nexletol, which will cost around $10 per tablet. Esperion added that it is working with health insurance providers to help ensure broad coverage for the two drugs, noting that eligible patients with commercial drug insurance coverage may pay as little as $10 per fill, up to a three-month supply.
For related analysis, read ViewPoints: Esperion can initiate long-awaited payer discussions unencumbered, and Physician Views snap poll: How will cardiologists utilise Esperion's newly approved Nexletol?
To read more Top Story articles, click here.