Summary
EMA’s human medicines committee recommended six new medicines and five extensions of existing medicines’ indications at its 12–15 October 2026 meeting. The recommendations are not final EU marketing authorisations.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines after meeting from 12 to 15 October 2026. The committee also recommended five extensions to existing medicines’ indications and a change that would make the emergency opioid-overdose medicine Nyxoid available without a prescription. These are committee recommendations; EMA listed the new-medicine recommendations as pending European Commission decisions.
Six new medicines recommended
The recommendations cover several types of treatment. Rasonque (daraxonrasib) was recommended for adults with metastatic pancreatic adenocarcinoma who have received at least one previous treatment. EMA said it had been prioritised through the Cancer Medicines Pathfinder project because of its potential to address an unmet medical need.
Foundayo (orforglipron) is an oral GLP-1 receptor agonist recommended for weight management and type 2 diabetes in adults. EMA describes it as a once-daily tablet and an alternative to injectable and other oral GLP-1 receptor agonists.
Yuviwel (navepegritide) was recommended for children with achondroplasia, an inherited condition associated with a mutation in the fibroblast growth-factor receptor 3 gene that affects the growth of bones throughout the body.
Two recommendations are for biosimilar medicines. Fovlussea (ranibizumab) was recommended for neovascular, or wet, age-related macular degeneration and other specified visual impairments, including those associated with diabetic macular oedema and retinal vein occlusion. Neuzafy (filgrastim) was recommended for neutropenia in adults and children. Biosimilars are medicines developed to be highly similar to an already authorised biological medicine.
The sixth recommendation is for Kizfizo (temozolomide), for adults with glioblastoma multiforme and children with malignant glioma. EMA describes its application as a hybrid: it draws partly on preclinical and clinical results for an already authorised reference medicine and partly on new data.
Other outcomes from the meeting
The CHMP recommended extending the therapeutic indications of five medicines already authorised in the EU: Pandemic influenza vaccine H5N1 AstraZeneca, Kyinsu, Talvey, Tryngolza and Tukysa.
After re-examining its earlier opinion, the committee confirmed its recommendation to refuse marketing authorisation for Yartemlea (narsoplimab). The medicine was intended for adults and children aged two years and older with thrombotic microangiopathy associated with a haematopoietic stem cell transplant.
Two applications to extend existing medicines’ indications were withdrawn. The application for Ibrance (palbociclib) concerned maintenance treatment for adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer. The application for Truqap (capivasertib) concerned metastatic prostate cancer that responds to hormone treatment when the cancer cells lack PTEN.
The committee did not recommend extending Mylotarg to children aged one to under 18 with newly diagnosed acute myeloid leukaemia, but agreed that relevant study data should be added to the medicine’s product information. It also recommended changing Nyxoid’s legal status so the naloxone nasal spray, used in suspected or known opioid overdose, could be supplied without a medical prescription.
A CHMP recommendation is a regulatory step rather than the final EU marketing-authorisation decision. EMA said the European Commission decisions on the new-medicine recommendations were pending.