CHMP Meeting Highlights February 2026 New
This month, medicinal products for the following indications have received a positive opinion:
- human African trypanosomiasis
- influenza and COVID-19 vaccine
- low-grade glioma
- Parkinson's disease
- Acromegaly
- chronic spontaneous urticaria
- WHIM syndrome
New medicines recommended for approval:
Acoziborole Winthrop (Acoziborole): has received a positive opinion for the treatment of both first-stage (hemo-lymphatic) and second-stage (meningo-encephalitic), including severe second-stage with ≥ 100 White Blood Cell (WBC)/μL with or without trypanosomes in cerebrospinal fluid (CSF), human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense (g-HAT) in adolescents ≥ 12 years old with body weight ≥ 40 kg, and in adults.
HAT or sleeping sickness is a life-threatening disease caused by the parasites Trypanosoma brucei gambiense and rhodesiense. T. brucei gambiense causes 92% of the reported cases. HAT is mostly transmitted through tsetse flies. In the first stage symptoms are fever, headache, joint pain and itching. In the secons stage the parasite crosses the blood-brain-barrier and causes behaviour changes, confusion and sleep cycle disturbance.
Acoziborole binds to the cleavage and polyadenylation specificity factor 3 (CPSF3) of T. brucei and inhibits the maturation of the mRNA and therefor the replication of T. brucei.
Acoziborole Winthrop was reviewed under EMA’s accelerated assessment and the EU-M4all programme. It is intended for use outside the European Union and a news announcement was release by the EMA for this product. For more information please consult the product for Acoziborole Winthrop on the EMA website.
mCombriax (Influenza and COVID 19, mRNA vaccine): has received a positive opinion for the active immunization n for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older.
mCombriax is a combination vaccine against the seasonal influenza virus strains A/H1N1, A/H3N2 and B/Victoria and COVID-19. It consists of mRNA of the aemagglutinin glycoproteins of influenza and parts of the SARS-CoV-2 spike protein. With the mRNA the human body can produce these viral proteins and antibodies against them. A news announcement was release by the EMA for this product. For more information please consult the product for mCombriax on the EMA website.
Ojemda (tovorafenib): has received a positive opinion for the conditional marketing authorisation for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.
Low-grade glioma are slowly growing tumours of the central nervous system. Glial cell are non-neuronal cells - they don’t produce electrical impulses - of the nervous system. Their function is to support and protect the neurons.
Ojemda is a BRAF inhibitor and mutations and alternations of the BRAF kinase are known as oncogenic driver mutations thus initiate and sustain cancer growth. By inhibiting BRAF the growth of the tumours is slowed down. An orphan designation was granted for the treatment of this disease and a news announcement was release by the EMA for this product. For more information please consult the product for Ojemda on the EMA website.
Onerji (levodopa / carbidopa): has received a positive opinion for the treatment of motor fluctuations in patients with advanced Parkinson's disease which are not sufficiently controlled by oral anti-Parkinson medicinal products.
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 Onerji on the EMA website.
Palsonify (paltusotine): has received a positive opinion for the medical treatment of adult patients with acromegaly.
Acromegaly is a hormonal disorder that develops when the pituitary gland produces too much growth hormone after normal growth has stopped. This causes bones to increase in size, leading to enlarged hands, feet, and facial features. It can also cause health problems like heart disease and diabetes.
Palsonify is somatostatin receptor 2 agonist. Somatostatin regulates the secretion of growth hormones and Palsonify mimics this, leading to decreased levels of growth hormone. An orphan designation was granted for the treatment of this disease. For more information please consult the product for Palsonify on the EMA website.
Rhapsido (remibrutinib): has received a positive opinion for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.
Chronic Spontaneous Urticaria (CSU) is a skin condition causing recurring hives and swelling for more than six weeks without a clear identifiable trigger.
Rhapsido is an irreversible Bruton’s tyrosine kinase (BTK) inhibitor. BTK is a key signaling protein in basophils and mast cells by inhibiting it the release of histamine and inflammatory mediators is reduced. For more information please consult the product for Rhapsido on the EMA website.
Xolremdi (mavorixafor): has received a positive opinion for a marketing authorisation under exceptional circumstances for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) in patients 12 years of age and older to increase the number of circulating mature neutrophils and lymphocytes.
The WHIM syndrome is a rare disease caused by mutations in the CXCR4 receptor gene and an increased responsiveness to the chemokine CXCL12. CXCR4 and CXCL12 regulate the retention of leukocytes in the bone marrow. The increased responsiveness of CXCR4 lead to a depletion of leukocytes in the body. Xolremdi is a CXCR4 antagonist and inhibits the interaction of CXCR4 and CXCL12. This reduces the adhesion of the leukocytes in the bone marrow. An orphan designation was granted for the treatment of this disease. For more information please consult the product for Xolremdi on the EMA website.
Recommendations on extensions of therapeutic indication:
Dupixent (dupilumab): extension of indication for Dupixent to include the treatment of moderate to severe chronic spontaneous urticaria in adults, and adolescents, and children (2 years and above) with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU. Previously the age limit was 12 years of age. For more information please consult the product for Dupixent on the EMA website.
Jorveza (budesonide): extension of indication for Jorveza to include the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age. Jorveza is already authorised for the treatment of adult patients. For more information please consult the product for Jorveza on the EMA website.
Keytruda (pembrolizumab): extension of indication for Keytruda to include in combination with paclitaxel, with or without bevacizumab the treatment of platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PDL1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens. Keytruda is already authorised for the treatment of other types of cancer. For more information please consult the product for Keytruda on the EMA website.
Olumiant (baricitinib): extension of indication for Olumiant to include the treatment of severe alopecia areata in adult and adolescent patients 12 years of age and older. Olumiant is already authorised for the treatment of adult patients. For more information please consult the product for Olumiant on the EMA website.
Scemblix (asciminib): extension of indication for Scemblix to include the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib. Scemblix is already authorised for the treatment of Ph+ CML-CP without the T315I mutation. For more information please consult the product for Scemblix on the EMA website.
Stelara (ustekinumab): extension of indication for Stelara to include the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Previously was a weight cut-off of 40 kg in paediatric patients. For more information please consult the product for Stelara 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:
Aqneursa: is indicated for the treatment of neurological manifestations of Niemann-Pick type C (NPC) disease, in combination with miglustat, or as a monotherapy in patients where miglustat is not tolerated, in adults and children aged 6 years and older and weighing at least 20 kg. EPAR Aqneursa.
Aumseqa: as monotherapy is indicated for:
- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC. EPAR Aumseqa.
Dawnzera: is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. EPAR Dawnzera.
Kyinsu: is indicated for the treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products. EPAR Kyinsu.
mNexspike: is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. EPAR mNexspike.
Myqorzo: is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. EPAR Myqorzo.
Teizeild: is indicated to delay the onset of stage 3 type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with stage 2 T1D. EPAR Teizeild.
Waskyra: is indicated for the treatment of patients aged 6 months and older with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene for whom haematopoietic stem cell (HSC) transplantation is appropriate and no suitable human leukocyte antigen (HLA)-matched related haematopoietic stem cell donor is available. EPAR Waskyras.
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-highlights
