CHMP's positive opinion clears path for NewAmsterdam and Menarini to launch obicetrapib-based cholesterol therapies in Europe
Executive summary: CHMP adopted a positive opinion recommending EU marketing authorization for obicetrapib monotherapy (Ubeslo) and the fixed‑dose obicetrapib/ezetimibe combination (Evlarco). A positive CHMP opinion is a key regulatory step toward market entry, potentially providing patients with a novel LDL‑cholesterol‑lowering therapy and creating revenue opportunities for NewAmsterdam Pharma and Menarini.
Who is involved: NewAmsterdam Pharma, Menarini Group, the European Medicines Agency’s CHMP, and the upcoming European Commission decision‑making body.
Likely next: The European Commission is expected to grant formal marketing authorization in the second half of 2026, after which the companies will prepare for launch, pricing and reimbursement negotiations in major EU markets.
The Committee for Medicinal Products for Human Use (CHMP) issued a favorable opinion recommending marketing authorization for obicetrapib monotherapy (Ubeslo) and its fixed‑dose combination with ezetimibe (Evlarco). The recommendation is based on positive Phase III trial data from the BROADWAY, BROOKLYN and TANDEM studies. If endorsed by the European Commission, the drugs could enter the European market in late 2026 or early 2027, offering a new LDL‑lowering option. The development reinforces Menarini’s pipeline expansion and NewAmsterdam’s strategy to commercialize its lead asset.
Timeline
- — NewAmsterdam Pharma et le groupe Menarini reçoivent un avis favorable du CHMP recommandant l'autorisation de mise sur le marché d'Ubeslo® (obicetrapib en monothérapie) et d'Evlarco® (association à dose fixe d'obicetrapib et d'ézétimibe) (PR Newswire)
- — NewAmsterdam Pharma y Menarini Group reciben una opinión positiva del CHMP sobre Ubeslo® (PR Newswire)
- — NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) (PR Newswire)
Analysis — what this means
Likely next events
- European Commission decision on marketing authorization expected by Q4 2026 (Oct‑Dec 2026).
- Menarini to initiate EU pricing and reimbursement discussions with HTA bodies in Germany, France and Italy starting September 2026.
- NewAmsterdam may file for U.S. FDA submission in early 2027 based on positive EU outcome.
- Potential launch of Ubeslo and Evlarco in key EU markets (Germany, France, Italy, Spain) Q1 2027.
Sectors affected
- cardiovascular therapeutics
- LDL‑cholesterol‑lowering drugs
- pharmaceutical manufacturing
- EU health‑technology assessment
Regulatory implications
- CHMP positive opinion triggers the centralized EU marketing authorization procedure; final EC decision anticipated Q4 2026.
- If approved, obicetrapib will be subject to EU pharmacovigilance and post‑authorization safety study requirements.
- National HTA agencies will conduct price‑and‑reimbursement assessments, likely influencing launch timing and market access.
Historical parallels
- 2015 CHMP recommendation leading to EU approval of evolocumab (Repatha) for PCSK9 inhibition.
- 2020 CHMP positive opinion for bempedoic acid (Nilemdo) as an oral LDL‑lowering agent.
- 2018 CHMP approval of inclisiran (Leqvio) siRNA therapy for hypercholesterolemia.
Key entities
Sources
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