The EU’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for 14 new medicines in its July meeting.
The following novel medicines and biosimilars each received a positive opinion:
- Abrysvo (bivalent, recombinant), a vaccine to protect small infants and older people against lower respiratory tract disease caused by respiratory syncytial virus (RSV).
- Apretude (cabotegravir) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection.
- Degarelix Accord (degarelix acetate), a generic medicine for the treatment of prostate cancer.
- Enrylaze (crisantaspase) for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma, an aggressive type of non-Hodgkin lymphoma.
- Inaqovi (decitabine/cedazuridine) for the treatment of acute myeloid leukaemia.
- Litfulo (ritlecitinib) for the treatment of severe alopecia areata.
- Lyfnua (gefapixant), intended for the treatment of refractory or unexplained chronic cough.
- Orserdu (elacestrant) for the treatment of postmenopausal women and men with locally advanced or metastatic breast cancer.
- Talvey (talquetamab) for the treatment of adult patients with relapsed and refractory multiple myeloma.
- Tepkinly (epcoritamab) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
- Tevimbra (tislelizumab) received a positive opinion from the CHMP for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.
- Tyenne (tocilizumab), a biosimilar medicine intended for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19.
- Tyruko (natalizumab) received a positive opinion as therapy for active relapsing remitting multiple sclerosis.
- Yesafili (aflibercept), a biosimilar treatment of age-related macular degeneration.
Rejections, extensions and withdrawals
The Committee recommended the refusal of a marketing authorisation for Krazati (adagrasib), which was intended for the treatment of patients with advanced non-small cell lung cancer with a specific mutation, G12C, in the KRAS protein.
Seven extensions of indication for medicines that are already authorised in the EU were also recommended: Bylvay, Ervebo, Evrysdi, Keytruda, Olumiant, Opdivo and Spikevax.
Three applications for marketing authorisation were withdrawn: Gefzuris, a duplicate of Lyfnua for the treatment of refractory or unexplained chronic cough, Jesduvroq for the treatment of adult patients with anaemia associated with chronic kidney disease, and Lagevrio, for the treatment of Covid-19.