Green light for twelve new medicines in the EU
The European Medicines Agency’s (EMA) key human medicines committee (CHMP) has recommended twelve medicines for approval at its July 2026 meeting. This brings to 54 the number of products approved in 2026.
The committee recommended granting marketing authorisations for three medicines to treat adults with primary hypercholesterolaemia or mixed dyslipidaemia, conditions that cause high cholesterol levels in the blood: Lyrokaul (lerodalcibep) is an injection that patients can self-administer monthly; Evlarco (obicetrapib / ezetimibe) and Ubeslo (obicetrapib) are both oral formulations to be taken daily.
The other nine products to get the green light were:
- Susvimo (rabinizumab) to treat adults with neovascular (wet) age-related macular degeneration.
- Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and adolescents from 12 years of age.
- Lynavoy (linerixibat) for the treatment of adults with cholestatic pruritus.
- Nezglyal (leriglitazone) for the treatment of cerebral adrenoleukodystrophy, a rare genetic disorder which affects the brain, typically during childhood.
- Zokovea (ensitrelvir), an antiviral medicine, for the post-exposure prophylaxis of COVID-19.
- Cavoley (pegfilgrastim) for the treatment of neutropenia (low levels of neutrophils, a type of white blood cell).
- Riociguat Accord (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension in adults and treatment of pulmonary arterial hypertension in adults and children from 6 years of age.
- Ruxolitinib Viatris (ruxolitinib hemifumarate) for the treatment of myelofibrosis, polycythaemia vera and graft-versus-host disease.
- Tafamidis Accord (tafamidis) for the treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.
The CHMP recommended extensions of indication for eight medicines that are already authorised in the EU: Enhertu, Jivi, Piqray, Repatha, Riltrava Aerosphere, Rinvoq, Trixeo Aerosphere, and Trodelvy.
The committee also approved an update of the composition of the vaccines Bimervax, Comirnaty, Nuvaxovid and Spikevax to target the new XFG variant of the virus that causes COVID-19.
