At its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for marketing authorisation (three generics, one biosimilar, and eight extensions of indication), while issuing negative opinions on three applications.
The most notable recommendation was for Susvimo (ranibizumab), the first refillable ocular implant approved in the EU for neovascular age-related macular degeneration. Rather than the monthly intravitreal injections patients currently require, Susvimo releases ranibizumab continuously and is refilled surgically every six months. A Phase 3 trial of 415 patients found it comparable to standard four-weekly injections in maintaining vision, a result that could meaningfully ease treatment burden for patients and health systems alike.
Also significant is Icotyde (icotrokinra), which will become the first oral medicine targeting the interleukin-23 receptor for moderate to severe plaque psoriasis, an option previously available only via injectable biologics. Across four Phase 3 trials involving 2,500 patients, three of the studies showed that 50–57% of patients achieved a 90% or greater improvement in symptom scores after 16 weeks, against just 1–4% on placebo, a gap wide enough to signal a genuine shift in the treatment landscape for this indication.
On the cardiometabolic side, three medicines targeting primary hypercholesterolaemia and mixed dyslipidaemia received positive opinions: Lyrokaul (lerodalcibep), a monthly self-administered injection, and two oral options, Evlarco (obicetrapib/ezetimibe) and Ubeslo (obicetrapib), broadening the toolkit available alongside existing lipid-lowering therapies.
The Committee adopted negative opinions for three applications: KemSu (sufentanil/ketamine) for paediatric acute pain, Meplyffa (arimoclomol citrate) for Niemann-Pick disease type C, and Qezzaqar (catequentinib) for soft tissue sarcomas.
Among indication extensions, eight already-authorised medicines gained wider approved uses: Enhertu, Jivi , Piqray, Repatha, Riltrava Aerosphere, Rinvoq, Trixeo Aerosphere and Trodelvy. Separately, three applications were withdrawn: a new marketing authorisation for Azacitidine Adienne, and extension applications for Dupixent (bullous pemphigoid) and Imfinzi (non-muscle invasive bladder cancer).
Separately, the Committee endorsed updating the composition of the COVID-19 vaccines Bimervax, Comirnaty, Nuvaxovid and Spikevax to target the XFG variant ahead of the 2026/2027 vaccination campaign, following the recommendation from the EMA’s Emergency Task Force.
Minutes of the 20-23 July meeting will be published in the coming weeks. For the full set of opinions, statistics and related documents, see the EMA’s own meeting highlights from the CHMP.
