Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023

News 10/11/2023

Eight new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2023 meeting.

The CHMP adopted a positive opinion for Omjjara* (momelotinib), for the treatment of myelofibrosis, a rare blood cancer that affects the bone marrow.

Rystiggo* (rozanolixizumab), intended for the treatment of generalised myasthenia gravis, received a positive opinion. Myasthenia gravis is a chronic autoimmune neuromuscular condition that causes muscle weakness in different parts of the body.

A positive opinion was adopted for Spexotras* (trametinib) for the treatment of paediatric patients aged one year and older with glioma, a type of brain tumour that begins in glial cells (the cells that surround and support nerve cells).

The committee adopted positive opinions for two biosimilar medicines: Rimmyrah (ranibizumab), for the treatment of neovascular age-related macular degeneration, a progressive retinal macular disease causing gradual vision impairment mainly in the elderly; and Uzpruvo (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease.

Two generic medicines also received a positive opinion from the committee: Azacitidine Kabi (azacitidine), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia; and Naveruclif (paclitaxel), for the treatment of metastatic breast cancer, metastatic adenocarcinoma of the pancreas and non-small cell lung cancer.

Positive recommendation on a new medicine following re-examination

Following a re-examination, the CHMP recommended granting a conditional marketing authorisation for Krazati (adagrasib), for the treatment of adults with advanced non-small cell lung cancer with a G12C mutation in the KRAS gene whose disease has worsened after at least one systemic treatment.

A question-and-answer document is available in the grid below.

Recommendations on extensions of therapeutic indication for nine medicines

The committee recommended extensions of indication for nine medicines that are already authorised in the EU: Ayvakyt*, Evkeeza, Fluad Tetra, Jardiance, Keytruda, Mounjaro, NexoBrid, Talzenna, Veltassa.

Withdrawals of applications

One application for an initial marketing authorisation was withdrawn. Vijoice* was intended for the treatment of PIK3CA-related overgrowth spectrum, a genetic condition that causes a range of symptoms including malformations and abnormal growth or tumours affecting several tissues, such as the skin, bones, blood vessels and brain.

The marketing authorisation holder for Bylvay* withdrew an application to extend the use of this medicine to include the treatment of cholestatic pruritus in Alagille syndrome in patients aged six months or older.

Question-and-answer documents on these withdrawals are available in the grid below.

Start of referral

The CHMP started a review of antibiotic medicines containing azithromycin that are given by mouth or by injection. The review has been initiated at the request of the German medicines regulatory agency under Article 31 of Directive 2001/83/EC.

For more information, see the public health communication in the grid below.

Other updates

The CHMP agreed to update the product information for the anticoagulant medicine Pradaxa to remove a pharmaceutical form (powder and solvent for oral solution) and to change the existing indication for use in children under 18 years of age.

Agenda and minutes

The agenda of the November 2023 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.

CHMP statistics

Key figures from the November 2023 CHMP meeting are represented in the graphic below.

*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.

Positive recommendations on new medicines

Name of medicineOmjjara
Marketing-authorisation applicantGlaxosmithkline Trading Services Limited
Therapeutic indicationOmjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
More informationOmjjara: Pending EC decision


Name of medicineRystiggo
Marketing-authorisation applicantUCB Pharma
Therapeutic indicationTreatment of generalised myasthenia gravis (gMG)
More informationRystiggo: Pending EC decision


Name of medicineSpexotras
Marketing-authorisation applicantNovartis Europharm Limited; 
Therapeutic indicationTreatment of paediatric patients aged 1 year and older with glioma
More informationSpexotras: Pending EC decision


Positive recommendations on new biosimilar medicines

Name of medicineRimmyrah
Marketing-authorisation applicantQILU PHARMA SPAIN S.L.
Therapeutic indicationTreatment of neovascular age-related macular degeneration (AMD)
More informationRimmyrah: Pending EC decision


Name of medicineUzpruvo
Marketing-authorisation applicantSTADA Arzneimittel AG
Therapeutic indicationTreatment of plaque psoriasis, arthritis psoriatic and Crohn’s Disease
More informationUzpruvo: Pending EC decision


Positive recommendation on new generic medicines

Name of medicineAzacitidine Kabi
International non-proprietary name (INN)azacitidine
Marketing-authorisation applicantFresenius Kabi Deutschland GmbH
Therapeutic indicationTreatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML)
More informationAzacitidine Kabi: Pending EC decision


Name of medicineNaveruclif
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment of metastatic breast cancer
More informationNaveruclif: Pending EC decision


Positive recommendation on a new medicine following re-examination

Name of medicineKrazati
Marketing-authorisation applicantMirati Therapeutics B.V.
More informationKrazati: Pending EC decision


Withdrawals of initial marketing authorisation applications

Name of medicineVijoice 
Marketing-authorisation applicantNovartis EuropharmLimited
More informationVijoice: Withdrawn application


Positive recommendations on extensions of indications

Name of medicineAyvakyt
Marketing-authorisation holderBlueprint Medicines (Netherlands) B.V.
More informationAyvakyt: Pending EC decision


Name of medicineEvkeeza
Marketing-authorisation holderUltragenyx Germany GmbH
More informationEvkeeza: Pending EC decision


Name of medicineFluad Tetra 
COMMON NAMEinfluenza vaccine (surface antigen, inactivated, adjuvanted)
Marketing-authorisation holderSeqirus Netherlands B.V.
More informationFluad Tetra: Pending EC decision


Name of medicineJardiance
Marketing-authorisation holderBoehringer Ingelheim International GmbH
More informationJardiance: Pending EC decision


Name of medicineKeytruda 
Marketing-authorisation holderMerck Sharp & Dohme B.V.
More informationKeytruda: Pending EC decision


Name of medicineMounjaro
Marketing-authorisation holderEli Lilly Nederland B.V.
More informationMounjaro: Pending EC decision


Name of medicineNexoBrid
INNconcentrate of proteolytic enzymes enriched in bromelain 
Marketing-authorisation applicantMediWound Germany GmbH
More informationNexoBrid: Pending EC decision


Name of medicineTalzenna
Marketing-authorisation applicantPfizer Europe MA EEIG
More informationTalzenna: Pending EC decision


Name of medicineVeltassa
Marketing-authorisation applicantVifor Fresenius Medical Care Renal Pharma France
More informationVeltassa: Pending EC decision

Withdrawal of application to change the marketing authorisation

Name of medicineBylvay
Marketing-authorisation applicantAlbireo
More informationBylvay: Withdrawn application


Start of referral

Name of medicineAzithromycin-containing medicinal products for systemic use 
Marketing-authorisation applicantVarious companies 
More informationAzithromycin-containing medicinal products for systemic use


Other updates

Name of medicinePradaxa
Marketing-authorisation applicantBoehringer Ingelheim International GmbH
More informationPradaxa: Pending EC decision


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