Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026
Eight new medicines recommended for approval; another 13 medicines recommended for extension of their therapeutic indications
NewsHumanMedicines
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2026 meeting.
Jascayd (nerandomilast) received a positive opinion from the CHMP for the treatment of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), two serious lung diseases that involve progressive and irreversible scarring (fibrosis) of the lung tissue. There are limited treatment options for people suffering from IPF or PPF. Both conditions can cause severe symptoms, including difficulty breathing, leading to hospitalisation and ultimately death within a few years of diagnosis due to a progressive decline in lung function. See more details in the news announcement in the grid below.
The CHMP recommended granting a conditional marketing authorisation for Vijoice (alpelisib), for the treatment of patients with severe PIK3CA-related overgrowth spectrum (PROS) disorders. PROS is a diverse group of rare genetic conditions that are characterised by uncontrolled growth of some tissues in the body, causing malformations and tumours affecting the skin, bones, blood vessels and brain. There is currently no authorised medicine for PROS and treatment consists of supportive care, including surgery and procedures to block overgrown blood vessels. See more details in the news announcement in the grid below.
The committee recommended granting a marketing authorisation for Boey (trenibotulinumtoxinE), for the temporary improvement in the appearance of moderate to severe lines between the eyebrows when these have an important psychological impact in adults.
The CHMP adopted a positive opinion for Etcamah (camizestrant), for the treatment of adults with locally advanced or metastatic breast cancer with a specific mutation in the ESR1 gene.
The CHMP recommended granting a marketing authorisation for three hybrid applications, which rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data:
- Ablymico (liraglutide), indicated for weight management.
- Liraglutide STADA (liraglutide), for the treatment of insufficiently controlled type 2 diabetes as an adjunct to diet and exercise.
- Colchicine AGEPHA Pharma (colchicine), for the secondary prevention of atherothrombotic events in adults with coronary disease who have been stable for at least six months.
A biosimilar medicine, Vislyfa (ranibizumab), received a positive opinion for the treatment of several eye diseases causing vision impairment.
Negative opinion for one medicine
The committee recommended not granting a marketing authorisation for Deqtynet (copper (64Cu) oxodotreotide), a diagnostic medicine intended for use with positron emission tomography (PET) imaging to detect well-differentiated neuroendocrine tumours (NETs) in adults. Neuroendocrine tumours are rare tumours that can develop in different parts of the body, such as the pancreas, intestines or lungs. Well-differentiated means that the cells look and behave like normal cells and grow slowly.
For more information on this negative opinion, see the question-and-answer document in the grid below.
Recommendations on extensions of therapeutic indication for 13 medicines
The committee recommended extensions of indication for 14 medicines that are already authorised in the European Union (EU):
Braftovi, Enhertu, Erbitux, Fasenra, Hetronifly, Iclusig, Keytruda, Maviret, Padcev, Palynziq, Sogroya, Tepkinly and Trodelvy.
Withdrawal of applications
Applications for initial marketing authorisation for two medicines were withdrawn:
- Orblid (bevacizumab), for the treatment of hereditary haemorrhagic telangiectasia, a genetic disease that causes abnormalities in the capillaries (small blood vessels that connect arteries with veins).
- Veblocema (infliximab), for the treatment of rheumatoid arthritis, Crohn’s disease and ulcerative colitis.
Question-and-answer documents on the withdrawal of these two applications are available in the grid below.
Other updates
The CHMP has recommended an extension to the marketing authorisation for Wegovy (semaglutide) for weight management to add a daily oral tablet as alternative formulation to weekly subcutaneous injections. Wegovy tablets can be used, together with diet and physical activity, in adults with obesity, or in those who are overweight and have at least one weight-related comorbidity. This is the first glucagon-like peptide (GLP-1) receptor agonist for weight management developed for oral use.
See more details in the news announcement in the grid below.
CHMP statistics
Key figures from the May 2026 CHMP meeting are represented in the graphic below.
May 2026 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:
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8 positive opinions on new medicines: 3 new non-orphan medicine, 1 orphan medicines, 1 biosimilar and 3 generic, hybrid or informed consent medicine. Total in 2026: 36
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1 negative opinions on new medicines. Total in 2026: 3
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18 positive opinions on extensions of therapeutic indication. Total in 2026: 59
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2 withdrawn applications for new medicines. Total in 2026: 5
Positive recommendations on new medicines
Boey
- INN
trenibotulinumtoxinE
- Marketing authorisation applicant
AbbVie Deutschland GmbH & Co
- Therapeutic indication
Temporary improvement in the appearance of moderate to severe lines between the eyebrows when these have an important psychological impact in adult patients
- More information
Etcamah
- INN
camizestrant
- Marketing authorisation applicant
Astra Zeneca
- Therapeutic indication
Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1‑mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor (for biomarker based patient-selection, see section 4.2 and 5.1)
- More information
Jascayd
- INN
nerandomilast
- Marketing authorisation applicant
Boehringer Ingelheim International GmbH
- Therapeutic indication
Treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF) and adult patients with Progressive Pulmonary Fibrosis (PPF)
- More information
- News
Vijoice
- INN
alpelisib
- Marketing authorisation applicant
Novartis Europharm Limited
- Therapeutic indication
Vijoice is indicated for the treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy
- Orphan designation
This medicine was designated an orphan medicine
- More information
- News
Positive recommendations on new hybrid medicines
Ablymico
- INN
liraglutide
- Marketing authorisation applicant
STADA Arzneimittel AG
- Therapeutic indication
Treatment of diabetes and weight management
- More information
Liraglutide STADA
- INN
liraglutide
- Marketing authorisation applicant
STADA Arzneimittel AG
- Therapeutic indication
Treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise
- More information
Colchicine AGEPHA Pharma
- INN
colchicine
- Marketing authorisation applicant
Agepha Pharma s.r.o.
- Therapeutic indication
Indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in patients with atherosclerotic disease or with multiple risk factors for cardiovascular disease
- More information
Positive recommendations on new biosimilar medicine
Vislyfa
- INN
ranibizumab
- Marketing authorisation applicant
Lupin Europe GmbH
- Therapeutic indication
The treatment of neovascular (wet) age-related macular degeneration (AMD); The treatment of visual impairment due to diabetic macular oedema (DME) - The treatment of proliferative diabetic retinopathy (PDR); The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); The treatment of visual impairment due to choroidal neovascularisation (CNV)
- More information
Negative recommendations on new medicines
Deqtynet
- INN
copper (64Cu) oxodotreotide
- Marketing authorisation applicant
Cis Bio International
- Therapeutic indication
For positron emission tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated neuroendocrine tumours (NETs) excluding neuroblastomas
- Orphan designation
This medicine was designated an orphan medicine.
- More information
Positive recommendations on extensions of therapeutic indications
Braftovi
- INN
encorafenib
- Marketing authorisation holder
Pierre Fabre Medicament
- More information
Enhertu
- INN
trastuzumab deruxtecan
- Marketing authorisation holder
Daiichi Sankyo Europe GmbH
- More information
Erbitux
- INN
cetuximab
- Marketing authorisation holder
Merck Europe B.V.
- More information
Fasenra
- INN
benralizumab
- Marketing authorisation holder
AstraZeneca AB
- More information
Hetronifly
- INN
serplulimab
- Marketing authorisation holder
Accord Healthcare S.L.U.
- More information
Iclusig
- INN
ponatinib
- Marketing authorisation holder
Incyte Biosciences Distribution B.V.
- More information
Keytruda
- INN
pembrolizumab
- Marketing authorisation holder
Merck Sharp & Dohme B.V.
- More information
Maviret
- INN
glecaprevir / pibrentasvir
- Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
- More information
Padcev
- INN
enfortumab vedotin
- Marketing authorisation holder
Astellas Pharma Europe B.V.
- More information
Palynziq
- INN
pegvaliase
- Marketing authorisation holder
BioMarin International Limited
- More information
Sogroya
- INN
somapacitan
- Marketing authorisation holder
Novo Nordisk A/S
- More information
Tepkinly
- INN
epcoritamab
- Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
- More information
Trodelvy
- INN
sacituzumab govitecan
- Marketing authorisation holder
Gilead Sciences Ireland Unlimited Company
- More information
Veblocema
- INN
infliximab
- Marketing authorisation holder
Celltrion Healthcare Hungary Kft.
- More information
Orblid
- INN
bevacizumab
- Marketing authorisation holder
Laboratoires Delbert
- More information
Other updates
Wegovy
- INN
semaglutide
- Marketing authorisation holder
Novo Nordisk A/S
- More information
- News