Evlarco

Opinion

EMA has issued an opinion on this medicine

obicetrapib / ezetimibe

Overview

On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Evlarco, intended for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia.

The applicant for this medicinal product is A. Menarini International Licensing S.A.

Evlarco will be available as 10 mg / 10 mg film-coated tablets. The active substances of Evlarco are obicetrapib and ezetimibe, both lipid-modifying agents (ATC code: C10BA17). Obicetrapib blocks a blood protein called CETP thereby lowering the level of LDL cholesterol. Ezetimibe blocks a protein in the gut wall (NPC1L1) that absorbs cholesterol from food and bile, leading to decreased blood levels of LDL cholesterol. 

The benefit of Evlarco is that it lowers LDL cholesterol (“bad” cholesterol) compared with placebo, as observed in 12-week randomised, double‑blind, placebo‑controlled study in adults with high cholesterol and/or atherosclerotic cardiovascular disease or multiple atherosclerotic cardiovascular disease risk factors who were already receiving the maximum tolerated cholesterol-lowering treatment. The most common side effects are hypertension, dizziness, headache, diarrhoea and abdominal pain.

The full indication is:

Evlarco is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

• in combination with a statin in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin in addition to ezetimibe or,
• alone in patients who are either statin-intolerant or for whom a statin is contraindicated and are unable to reach LDL-C goals with ezetimibe alone or,
• in patients already being treated with the combination of obicetrapib and ezetimibe as separate tablets with or without statin.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Evlarco

Adopted Reference Number: EMADOC-1829012207-57694

Product details

• Name of medicine:
  Evlarco
• Active substance:
  • ezetimibe
  • obicetrapib hemicalcium
• International non-proprietary name (INN) or common name:
  • obicetrapib
  • ezetimibe
• Therapeutic area (MeSH):
  • Hypercholesterolemia
  • Dyslipidemias
• Anatomical therapeutic chemical (ATC) code:
  C10B
• EMA product number:
  EMEA/H/C/006517
• Marketing authorisation applicant:
  A. Menarini International Licensing S.A.
• Opinion adopted:
  23/07/2026
• Opinion status:
  Positive