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:
The committee adopted negative opinions for three medicines:
For more information on these negative opinions, see the question-and-answer documents in the grid below.
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 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.
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.
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.
The July 2026 CHMP meeting agenda is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the July 2026 CHMP meeting are represented in the graphic below.
July 2026 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:
12 positive opinions on new medicines: 9 new non-orphan medicines, 2 orphan medicines, and 1 biosimilar medicine. Total in 2026: 54
3 negative opinions on new medicines. Total in 2026: 8
8 positive opinions on extensions of therapeutic indication. Total in 2026: 80
1 withdrawn application for new medicine. Total in 2026: 6
obicetrapib / ezetimibe
A. Menarini International Licensing S.A.
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia
icotrokinra hydrochloride
Janssen-Cilag International N.V.
Treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 years of age and older and weighing at least 40 kg
lerodalcibep
LIB Therapeutics B.V.
Treatment of adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and non-familial) or mixed dyslipidaemia as an adjunct to diets
leriglitazone
Minoryx Therapeutics S.L.
Treatment of cerebral adrenoleukodystrophy
This medicine was designated as an orphan medicine.
ranibizumab
Roche Registration GmbH
Treatment of adults with neovascular (wet) age-related macular degeneration
obicetrapib
A. Menarini International Licensing S.A.
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia
ensitrelvir
Shionogi B.V.
Post-exposure prophylaxis of COVID-19
pegfilgrastim
CuraTeQ Biologics s.r.o
Reduction of neutropenia in adults
riociguat
Accord Healthcare S.L.U.
Treatment of Chronic thromboembolic pulmonary hypertension (CTEPH) in adults and treatment of Pulmonary arterial hypertension (PAH) in adults and children from 6 years of age
ruxolitinib hemifumarate
Viatris Limited
Treatment of myelofibrosis (MF), polycythaemia vera (PV) and Graft versus host disease (GvHD)
tafamidis
Accord Healthcare S.L.U.
Treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTRh-CM)
sufentanil / ketamine
Proveca Pharma Limited
Treatment of acute pain in children aged 1 to less than 18 years
arimoclomol citrate
Zevra Denmark A/S
Treatment of Niemann-Pick disease type C in patients aged 2 years and older in combination with miglustat
This medicine was designated an orphan medicine.
catequentinib
CATS Consultants GmbH
Treatment of synovial sarcoma or leiomyosarcoma
This medicine was designated as an orphan medicine.
trastuzumab deruxtecan
Daiichi Sankyo Europe GmbH
damoctocog alfa pegol
Bayer AG
Jivi : pending EC decision - to be published shortly
alpelisib
Novartis Europharm Limited
evolocumab
Amgen Europe B.V.
upadacitinib
Abbvie Deutschland GmbH & Co. KG.
formoterol / glycopyrronium bromide / budesonide
AstraZeneca AB
formoterol / glycopyrronium bromide / budesonide
AstraZeneca AB
sacituzumab govitecan
Gilead Sciences Ireland Unlimited Company
azacitidine
dupilumab
durvalumab