Source: European Union 2
Twelve new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended twelve medicines for approval at its July 2026 meeting.
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. All three medicines are for use in addition to diet and can be taken alone or in combination with other lipid-lowering therapies.
Susvimo (rabinizumab) received a recommendation for marketing authorisation to treat adults with neovascular (wet) age-related macular degeneration. Susvimo is delivered via a refillable implant, the first of this kind approved in the EU, inserted surgically into the eye. The implant is designed to release ranibizumab over time and is refilled every six months. Susvimo represents a new treatment option for patients. For more information read the news announcement in the grid below.
The CHMP recommended granting a marketing authorisation for Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and adolescents from 12 years of age. Icotyde is the first oral medicine that targets the protein interleukin-23 receptor, thereby reducing inflammation and symptoms associated with the disease. See more details in the news announcement in the grid below.
Lynavoy (linerixibat) received a positive opinion from the CHMP for the treatment of adults with cholestatic pruritus, a complication of an autoimmune disease called primary biliary cholangitis in which there is gradual destruction of the bile ducts in the liver. Patients who develop cholestatic pruritus experience intense itching due to a build-up of bile acids in the bloodstream.
The committee also recommended granting a marketing authorisation under exceptional circumstances for Nezglyal (leriglitazone) for the treatment of cerebral adrenoleukodystrophy, a rare genetic disorder which affects the brain, typically during childhood.
Zokovea (ensitrelvir), an antiviral medicine, received a positive opinion for the post-exposure prophylaxis of COVID-19.
The committee adopted a positive opinion for the biosimilar medicine Cavoley (pegfilgrastim) for the treatment of neutropenia (low levels of neutrophils, a type of white blood cell).
Three generic medicines received a positive opinion:
- 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.
Negative opinion for three medicines
The committee adopted negative opinions for three medicines:
- KemSu (sufentanil / ketamine) for the treatment of acute pain in children aged 1 to less than 18 years.
- Meplyffa (arimoclomol citrate) intended for treatment of Niemann-Pick disease type C, a rare, inherited, progressive neurodegenerative disorder, in patients aged 2 years and older in combination with miglustat.
- Qezzaqar (catequentinib) intended for the treatment of synovial sarcoma or leiomyosarcoma, two types of soft tissue sarcomas (a type of cancer that affects the soft, supportive tissues of the body).
For more information on these negative opinions, see the question-and-answer documents in the grid below.
Recommendations on extensions of therapeutic indication for eight medicines
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.
Re-examinations of initial marketing authorisation applications
The company that applied for the authorisation of Yartemlea (narsoplimab), a medicine intended for the treatment of adults and children from 2 years of age with haematopoietic stem cell transplant-associated thrombotic microangiopathy, and the company that applied for the authorisation of Xervyteg (allogeneic faecal microbiota, pooled), a medicine developed to treat acute graft-versus-host disease, have requested re-examinations of the negative opinions adopted during the committee’s June 2026 meeting.
Question-and-answer documents on the refusal of marketing authorisations for these medicines are available on EMA’s website.
Withdrawal of applications
An application for initial marketing authorisation for Azacitidine Adienne (azacitidine), for the treatment of adults with certain disorders and cancers of the blood and bone marrow when they cannot have haematopoietic stem cell transplantation, was withdrawn. A question-and-answer document on the withdrawal of this application is available in the grid below.
Two applications for extensions of indications were withdrawn: one to extend the use of Dupixent (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid, an autoimmune skin disease that causes widespread itching and blisters affecting the skin and sometimes the inside of the mouth; and one to extend the use of Imfinzi (durvalumab) for the treatment of high-risk non-muscle-invasive bladder cancer, a type of cancer that affects the lining of the bladder.
Question-and-answer documents on the withdrawal of these two applications are available in the grid below.
Other updates
The CHMP gave a positive opinion to update the composition of the vaccines Bimervax, Comirnaty, Nuvaxovid and Spikevax to target the new XFG variant of the virus that causes COVID-19. The revision of these vaccines is in line with the recommendation issued by EMA’s Emergency Task Force for the 2026/2027 vaccination campaign.
Agenda and minutes
The July 2026 CHMP meeting agenda is published on EMA’s website. Minutes of the meeting will be published in the coming weeks.
CHMP statistics
Key figures from the July 2026 CHMP meeting are represented in the graphic below.