CHMP recommends 12 new medicines for approval
- Drug
- Cavoley, Evlarco, Icotyde, Lynavoy, Lyrokaul, Nezglyal, Susvimo, Ubeslo, Zokovea, Riociguat Accord, Ruxolitinib Viatris, Tafamidis Accord · pegfilgrastim; obicetrapib/ezetimibe; icotrokinra; linerixibat; lerodalcibep; leriglitazone; ranibizumab; obicetrapib; ensitrelvir; riociguat; ruxolitinib hemifumarate; tafamidis
- Indication
- multiple — see per-drug table
EMA's CHMP recommended 12 new medicines for approval at its 20-23 July 2026 meeting — 8 novel branded products (including three lipid-lowering approvals on the same day, Susvimo's port delivery implant, and the first oral IL-23R antagonist), one COVID-19 post-exposure antiviral, and three generics.
Read original at ema.europa.eu ↗From the source
CHMP plenary 20-23 July 2026 — 12 positive opinions for new medicines:
Novel branded (8): • Cavoley (pegfilgrastim biosimilar) — neutropenia • Evlarco (obicetrapib + ezetimibe FDC) — Menarini Group — primary hypercholesterolemia / mixed dyslipidemia • Icotyde (icotrokinra) — Johnson & Johnson — moderate-to-severe plaque psoriasis (12+); first oral IL-23R antagonist • Lynavoy (linerixibat) — GSK — cholestatic pruritus in primary biliary cholangitis • Lyrokaul (lerodalcibep) — LIB Therapeutics — primary hypercholesterolemia / mixed dyslipidemia (monthly SC self-administered) • Nezglyal (leriglitazone) — Minoryx Therapeutics — cerebral adrenoleukodystrophy (exceptional circumstances) • Susvimo (ranibizumab) — Genentech / Roche — wet AMD; first EU-approved refillable intravitreal implant, refilled every 6 months • Ubeslo (obicetrapib) — NewAmsterdam Pharma / Menarini — primary hypercholesterolemia / mixed dyslipidemia
Antiviral (1): • Zokovea (ensitrelvir) — Shionogi — COVID-19 post-exposure prophylaxis
Generics (3): • Riociguat Accord — Accord Healthcare — CTEPH / pulmonary arterial hypertension • Ruxolitinib Viatris (ruxolitinib hemifumarate) — Viatris — myelofibrosis / polycythemia vera / GvHD • Tafamidis Accord — Accord Healthcare — hereditary transthyretin amyloidosis with cardiomyopathy
Reproduced from EMA CHMP Meeting Highlights · view original · public domain or open-licensed government work