CHMP recommends EU approval for NewAmsterdam’s obicetrapib therapies, paving potential market entry
Executive summary: The CHMP adopted a positive opinion recommending EU marketing authorization for NewAmsterdam Pharma’s obicetrapib monotherapy (Ubeslo) and its obicetrapib/ezetimibe fixed‑dose combination (Evlarco), based on positive Phase 3 trial data. Approval would introduce a novel CETP inhibitor to the EU market, offering a new LDL‑C‑lowering option that could capture share from statins and PCSK9 inhibitors and generate fresh revenue for NewAmsterdam and Menarini.
Who is involved: NewAmsterdam Pharma, Menarini Group, the Committee for Medicinal Products for Human Use (CHMP) of the EMA, and the European Commission.
Likely next: The European Commission is expected to issue its final decision by late September 2026 (within 60 days of the CHMP opinion); if approved, launch in key EU markets such as Germany and Italy is planned for early 2027, followed by pricing and reimbursement negotiations.
The CHMP issued a positive opinion based on positive Phase 3 BROADWAY, BROOKLYN and TANDEM data, recommending marketing authorization for obicetrapib monotherapy (Ubeslo) and its fixed‑dose combination with ezetimibe (Evlarco). This step moves the novel CETP inhibitor closer to patients in the European Union, where it would compete with existing LDL‑lowering therapies such as statins and PCSK9 inhibitors. The final authorization decision now lies with the European Commission, which has approximately 60 days to act, with a decision expected by late September 2026.
Timeline
- — NewAmsterdam Pharma und die Menarini Group erhalten positive Stellungnahme des CHMP mit der Empfehlung zur Erteilung einer Zulassung für Ubeslo® (Obicetrapib-Monotherapie) und Evlarco® (Festsatzkombination aus Obicetrapib und Ezetimib) (PR Newswire)
- — 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 expected to issue final decision on Ubeslo/Evlarco authorization by Q4 2026 (approximately 60 days after the CHMP opinion, i.e., late September 2026)
- If approved, NewAmsterdam plans to launch Ubeslo in Germany and Italy in Q1 2027
- Menarini intends to seek reimbursement agreements with major EU health authorities by mid‑2027
Sectors affected
- Pharmaceuticals
- Lipid‑lowering therapy market
- Cardiovascular drugs
Regulatory implications
- CHMP positive opinion triggers the centralized EU authorization procedure; the European Commission has 60 days to adopt a final decision (expected by late September 2026)
- Post‑approval, the companies must submit a Phase IV safety study and comply with EU pharmacovigilance and post‑authorization safety study (PASS) requirements
- Once authorized, the drug will be subject to EU pricing and reimbursement negotiations under each member state’s health technology assessment (HTA) process
Historical parallels
- CHMP positive opinion for bempedoic acid (Nexletol) in July 2020 preceded EU marketing authorization in January 2021
- CHMP positive opinion for inclisiran (Leqvio) in October 2020 preceded EU approval in November 2020
- CHMP positive opinion for evolocumab (Repatha) in August 2015 preceded EU authorization in the same month
Key entities
Sources
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