Uitkomst CHMP (zoals verwacht geen uitsluitsel over leniolisib)
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One application for an initial marketing authorisation was withdrawn.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.