Eight medicines recommended for approval by CHMP

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026

22 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.

CHMP statistics: Text version

May 2026 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications:

• 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

• 1 negative opinions on new medicines. Total in 2026: 3

• 18 positive opinions on extensions of therapeutic indication. Total in 2026: 59

• 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 Boey : pending EC decision

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 Etcamah : pending EC decision

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 Jascayd : pending EC decision

News New medicine for two types of pulmonary fibrosis

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 Vijoice : pending EC decision

News First medicine to treat rare uncontrolled growth of body tissues

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 Ablymico : pending EC decision

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 Liraglutide STADA : pending EC decision

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 Colchicine AGEPHA Pharma : pending EC decision

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 Vislyfa: pending EC decision

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 Deqtynet : pending EC decision

Positive recommendations on extensions of therapeutic indications

Braftovi

INN encorafenib

Marketing authorisation holder Pierre Fabre Medicament

More information Braftovi : pending EC decision

Enhertu

INN trastuzumab deruxtecan

Marketing authorisation holder Daiichi Sankyo Europe GmbH

More information Enhertu: pending EC decision (EMA/VR/0000293327)

Erbitux

INN cetuximab

Marketing authorisation holder Merck Europe B.V.

More information Erbitux: pending EC decision (EMA/VR/0000326978) Erbitux: pending EC decision (EMA/VR/0000327014)

Fasenra

INN benralizumab

Marketing authorisation holder AstraZeneca AB

More information Fasenra: pending EC decision

Hetronifly

INN serplulimab

Marketing authorisation holder Accord Healthcare S.L.U.

More information Hetronifly: pending EC decision

Iclusig

INN ponatinib

Marketing authorisation holder Incyte Biosciences Distribution B.V.

More information Iclusig: pending EC decision

Keytruda

INN pembrolizumab

Marketing authorisation holder Merck Sharp & Dohme B.V.

More information Keytruda: pending EC decision (EMA/VR/0000312515) Keytruda: pending EC decision (EMA/VR/0000316576)

Maviret

INN glecaprevir / pibrentasvir

Marketing authorisation holder AbbVie Deutschland GmbH & Co. KG

More information Maivret : pending EC decision

Padcev

INN enfortumab vedotin

Marketing authorisation holder Astellas Pharma Europe B.V.

More information Padcev : pending EC decision

Palynziq

INN pegvaliase

Marketing authorisation holder BioMarin International Limited

More information Palynziq : pending EC decision

Sogroya

INN somapacitan

Marketing authorisation holder Novo Nordisk A/S

More information Sogroya : pending EC decision

Tepkinly

INN epcoritamab

Marketing authorisation holder AbbVie Deutschland GmbH & Co. KG

More information Tepkinly : pending EC decision

Trodelvy

INN sacituzumab govitecan

Marketing authorisation holder Gilead Sciences Ireland Unlimited Company

More information Trodelvy : pending EC decision

Withdrawal of initial marketing authorisation applications

Veblocema

INN infliximab

Marketing authorisation holder Celltrion Healthcare Hungary Kft.

More information Veblocema : questions and answers

Orblid

INN bevacizumab

Marketing authorisation holder Laboratoires Delbert

More information Orblid : questions and answers

Other updates

Wegovy

INN semaglutide

Marketing authorisation holder Novo Nordisk A/S

More information Wegovy : pending EC decision (EMA/X/0000296344)

News First oral GLP-1 treatment for weight management

Overview of (invented) names reviewed in April 2026 by the Name Review Group (NRG) adopted at the CHMP meeting of 21 May 2026

Adopted Reference Number: EMA/97170/2026

English (EN) (169.66 KB - PDF)

First published: 22/05/2026

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Related content

• Committee for Medicinal Products for Human Use (CHMP): 18-21 May 2026

• Committee for Medicinal Products for Human Use (CHMP)

News

• New medicine for two types of pulmonary fibrosis

• First medicine to treat rare uncontrolled growth of body tissues

• First oral GLP-1 treatment for weight management

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Related medicine information

• Boey

• Etcamah

• Jascayd

• Vijoice

• Ablymico

• Liraglutide STADA

• Colchicine Agepha Pharma

• Vislyfa

• Deqtynet

• Braftovi

• Enhertu

• Erbitux

• Fasenra

• Hetronifly

• Iclusig

• Keytruda

• Maviret

• Padcev

• Palynziq

• Sogroya

• Tepkinly

• Trodelvy

• Veblocema

• Orblid

• Wegovy