CHMP Backs Obicetrapib Ubeslo and Evlarco
CHMP recommends obicetrapib Ubeslo Evlarco as oral non-statin options for adults with primary hypercholesterolaemia or mixed dyslipidaemia. On 24 July 2026 NewAmsterdam Pharma and Menarini said EMA's human medicines committee adopted positive opinions for both the monotherapy and the ezetimibe fixed-dose combination.
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Key Takeaways
- CHMP recommended Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib/ezetimibe 10/10 mg) for HeFH and non-familial primary hypercholesterolaemia or mixed dyslipidaemia.
- EMA listed both among three new lipid medicines recommended in July 2026, alongside Lyrokaul (lerodalcibep).
- Sponsors cited up to ~40% LDL-C reduction for monotherapy and ~50% for the FDC versus placebo in Phase 3.
- European Commission decision expected in 2H26; Menarini holds EU commercial rights.
Obicetrapib EU opinions at a glance
| Field | Detail |
|---|---|
| Products | Ubeslo (obicetrapib); Evlarco (obicetrapib + ezetimibe FDC) |
| Class | Oral CETP inhibitor (plus ezetimibe in Evlarco) |
| Companies | NewAmsterdam Pharma; Menarini (EU commercial rights) |
| Regulator step | CHMP positive opinions (24 July 2026) |
| Use setting | Primary hypercholesterolaemia / mixed dyslipidaemia; with diet; alone or with other LLTs |
| Key Phase 3 | BROADWAY, BROOKLYN, TANDEM |
| Next step | European Commission decision expected 2H26 |
What did CHMP and EMA say?
EMA's July meeting highlights said Lyrokaul (lerodalcibep), Evlarco (obicetrapib/ezetimibe) and Ubeslo (obicetrapib) were recommended for adults with primary hypercholesterolaemia or mixed dyslipidaemia. Evlarco and Ubeslo are oral daily formulations for use in addition to diet, alone or with other lipid-lowering therapies.
See EMA CHMP 20–23 July 2026 meeting highlights and NewAmsterdam/Menarini's 24 July GlobeNewswire release.
What efficacy package supports the opinions?
The companies said BROADWAY, BROOKLYN and TANDEM delivered statistically significant LDL-C reductions of up to about 40% with monotherapy and about 50% with the ezetimibe combination versus placebo, with a placebo-like tolerability profile. Related registrations include NCT05142722 and NCT05425745 (HeFH) on ClinicalTrials.gov.
- PREVAIL cardiovascular outcomes trial (NCT05202509) remains ongoing for MACE endpoints
- REMBRANDT and RUBENS also continue in the broader programme
- Menarini is responsible for EU regulatory interactions and commercialisation
How does Menarini fit the European launch plan?
Under the licensing deal, Menarini holds exclusive commercialisation rights for obicetrapib in Europe and leads regional regulatory interactions. NewAmsterdam said it can earn tiered double-digit royalties on net sales in the Menarini territory plus up to an additional €833 million in clinical, regulatory and commercial milestones if future triggers are met.
Those economics do not change the clinical evidence bar. They do explain why both companies jointly announced the CHMP opinions and why Menarini will drive Member State access negotiations after any Commission decision.
What remains uncertain?
Positive CHMP opinions are not Commission approvals. Cardiovascular outcome data from PREVAIL are not yet the basis of this lipid-lowering recommendation. Exact labelled populations, statin background requirements, and HTA positioning versus PCSK9 inhibitors and bempedoic acid will be decided after authorisation.
Related NovaPharma coverage
- FDA approves MSD Lipfendra as first oral PCSK9
- ESC 2026 Preview: ACACIA-HCM Hot Line Watch
- EMA's CHMP Recommends Oral Wegovy Approval
Frequently Asked Questions
What did CHMP recommend for obicetrapib?
On 24 July 2026, EMA's CHMP recommended marketing authorisations for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination) for primary hypercholesterolaemia (including heterozygous familial) or mixed dyslipidaemia, as oral once-daily options alongside diet.
What LDL-C reductions did the companies cite?
NewAmsterdam and Menarini said Phase 3 BROADWAY, BROOKLYN and TANDEM showed statistically significant LDL-C reductions up to about 40% with obicetrapib monotherapy versus placebo and about 50% with obicetrapib plus ezetimibe versus placebo, with tolerability comparable to placebo.
When could EU authorisation be final?
The companies said a European Commission decision is expected in the second half of 2026. Menarini holds exclusive European commercialisation rights under the partners' licensing agreement.
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