CHMP Meeting Highlights June 2026 New
This month, medicinal products for the following indications have received a positive opinion:
- Influenza vaccine
- Rett syndrome
- Parkinson’s disease
- type 2 diabetes
New medicines recommended for approval:
Aujemflu (influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated): has received a positive opinion for the Prophylaxis of influenza in adults 50 years of age and older.
Aujemflu is a vaccine against the seasonal influenza virus strains A/H1N1, A/H3N2 and B/Victoria. It contains haemagglutinin and neuraminidase surface antigens from these inactivated influenza virus strains. For more information please consult the product for Aujemflu on the EMA website.
Daybu (trofinetide): has received a positive opinion for the treatment of neurobehavioural symptoms of Rett syndrome in adults and paediatric patients aged 5 years and older.
Rett syndrome is a rare, X linked neurodevelopmental disorder that almost exclusively affects girls. It is caused by mutations in the MECP2 gene, which encodes a protein essential for brain development and function. It is marked by an initial period of normal growth followed by a regression that includes loss of hand skills, speech, and social interaction, plus a host of motor, autonomic, and cognitive problems.
Daybu is a synthetic analogue of the N-terminal tripeptide of insulin-like growth factor 1. Its mechanism of action in the treatment of Rett syndrome is not fully understood. An orphan designation was granted for the treatment of this disease. For more information please consult the product for Daybu on the EMA website.
Hopledo (levodopa / carbidopa): has received a positive opinion for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilised with oral levodopa/dopa decarboxylase (DDC) inhibitor based treatment regimens.
Parkinson's Disease is a progressive nervous system disorder that affects movement. It's caused by a loss of dopamine-producing neurons in the brain, leading to tremors, stiffness, slowness of movement, and balance problems.
Levodopa is a precursor to dopamine. It crosses the blood-brain barrier (unlike dopamine itself), and then the brain converts it into dopamine. The increased dopamine level in the brain reduces the symptoms of Parkinson’s disease. Carbidopa is an inhibitor of the aromatic L-amino acid decarboxylase. This enzyme converts Levodopa to dopamine before it reaches the brain, by inhibiting it the levodopa is more effective and has less side effects. For more information please consult the product for Hopledo on the EMA website.
Onswik (insulin efsitora alfa): has received a positive opinion for the treatment of type 2 diabetes mellitus in adults.
Type 2 diabetes mellitus T2DM is a metabolic disease characterised by high blood sugar and insulin resistance and it accounts for around 90% of diabetes cases. Although some people can have certain genetic predisposition, T2DM occurs primarily as a result of obesity and sedentary lifestyle. The prevalence of T2DM continues to increase globally along with obesity and overweight.
Onswik is a modified insulin fused to an immunoglobulin G2 fragment (IgG2-Fc). The insulin was modified for a reduced affinity to the insulin receptor. The fused IgG2-Fc reduces the degradation of the insulin. These modifications allow the once weekly administration of Onswik for glycaemic control. For more information please consult the product for Onswik on the EMA website.
Recommendations on extensions of therapeutic indication:
Datroway (datopotamab deruxtecan): extension of indication for Datroway to include the the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is already authorised for the treatment of HR-Positive, HER2-Negative breast cancer. For more information please consult the product for Datroway on the EMA website.
Imvanex (smallpox and monkeypox vaccine (live modified vaccinia virus Ankara)): extension of indication for Imvanex Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in individuals 2 years of age and older. Previously the age limit was 12 years of age. For more information please consult the product for Imvanex on the EMA website.
Ixchiq (Chikungunya vaccine (live)): rescriciton of indication for Ixchiq to active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older at high risk of acquiring chikungunya infection. Previously there was no restriction to high-risk individuals. For more information please consult the product for Ixchiq on the EMA website.
Jaypirca (pirtobrutinib): extension of indication for Jaypirca to include the treatment of adult patients with chronic lymphocytic leukaemia (CLL). Jaypirca is already authorised for the treatment of mantle cell lymphoma. For more information please consult the product for Jaypirca on the EMA website.
Leqvio (inclisiran): extension of indication for Leqvio to include the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet, and in paediatric patients aged 12 years and older with heterozygous familial hypercholesterolaemia (HeFH):
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Previously it was only authorised for the treatment of adults. For more information please consult the product for Leqvio on the EMA website.
MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine): extension of indication for MenQuadfi to include the active immunisation of individuals from the age of 6 weeks and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. Previously the age limit was 12 months of age. For more information please consult the product for MenQuadfi on the EMA website.
Opzelura (ruxolitinib): extension of indication for Opzelura to include the treatment of moderate atopic dermatitis in adult patients for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate. Opzelura is already authorised for the treatment of vitiligo. For more information please consult the product for Opzelura on the EMA website.
Rezolsta (darunavir / cobicistat): extension of indication for Rezolsta to include in combination with other antiretroviral medicinal products, the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and paediatric patients aged 3 years and older, weighing at least 15 kg. Previously the age limit was 6 years of age, weighing at least 25 kg. For more information please consult the product for Rezolsta on the EMA website.
Rinvoq (upadacitinib): extension of indication for Rinvoq to include the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Rinvoq also received a positive opinion the treatment of non-segmental vitiligo in adults and adolescents 12 years and older who are candidates for systemic therapy. It is already approved for the treatment of different rheumatoid diseases. For more information please consult the product for Rinvoq on the EMA website.
Stelara (ustekinumab): extension of indication for Stelara to include the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic. Previously it was already authorised for the treatment of adults with ulcerative colitis. For more information please consult the product for Stelara on the EMA website.
Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide): extension of indication for Symtuza to include the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and paediatric patients aged 6years and older with body weight at least 25 kg. Previously the age limit was 12 years of age, weighing at least 40 kg. For more information please consult the product for Symtuza on the EMA website.
Tecvayli (teclistamab): extension of indication for Tecvayli to include combination with daratumumab the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. Tecvayli is already authorised for the treatment of multiple myeloma in a later line of therapy. For more information please consult the product for Tecvayli on the EMA website.
Newly published EPARs:
The EPAR (European public assessment report) is the main document where the EMA publishes detailed information on the medicines assessed by the CHMP. Below is a list of the EPARs for recently approved products that have been made available on the EMA homepage:
Adstiladrin: is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours. EPAR Adstiladrin.
Bopediat: is indicated in children from birth to less than 18 years of age for the treatment of oedema of cardiac or renal origin, oedema of hepatic origin, and hypertension in patients with chronic kidney disease. EPAR Bopediat.
Cenrifki: Cenrifki is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years. EPAR Cenrifki.
Imdylltra: is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy. EPAR Imdylltra.
Joenja: is indicated for the treatment of activated phosphoinositide 3 kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more. EPAR Joenja.
Zepzelca: in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. EPAR Zepzelca.
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-highlights
