The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) officially announced on October 16, 2026, that it has recommended six new medicines for marketing authorization following its plenary meeting held from October 12 to 15, 2026. This recommendation includes key new drugs such as Eli Lilly’s oral GLP-1 receptor agonist ‘Orforglipron’ and the pancreatic cancer treatment ‘Daraxonrasib’.
CHMP Recommends Approval for Oral GLP-1 ‘Orforglipron’ and Pancreatic Cancer Drug ‘Daraxonrasib’
According to the EMA CHMP announcement, ‘Orforglipron,’ developed by Eli Lilly Nederland B.V., has received a positive opinion for marketing authorization as an oral GLP-1 receptor agonist for weight management and the treatment of type 2 diabetes in adults. As a once-daily pill, Orforglipron is considered a significant alternative to existing injectable GLP-1 treatments.
Additionally, ‘Daraxonrasib’ (developed by Revolution Medicines Netherlands B.V.) has been recommended for marketing authorization for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior therapy. Daraxonrasib was designated as a high-priority medicine under the EMA’s ‘Cancer Medicines Pathfinder’ project, designed to address unmet medical needs, and underwent a phased review process.
6 New Recommendations: Rare Disease Therapies, Biosimilars, and Hybrid Drugs
The CHMP also recommended marketing authorization for ‘Navepegritide,’ developed by Ascendis Pharma, a treatment for pediatric achondroplasia. Achondroplasia is a genetic disorder where bone growth is inhibited due to mutations in the fibroblast growth factor receptor 3 (FGFR3) gene.
In the biosimilar category, two products received positive opinions: ‘Ranibizumab’ for the treatment of neovascular age-related macular degeneration and vision impairment, and ‘Filgrastim’ for the treatment of neutropenia. Furthermore, Orphalan’s hybrid application for ‘Temozolomide’ was recommended for approval for the treatment of adult glioblastoma and pediatric malignant glioma.
Expanded Indications, Re-examinations, and Other Decisions
The CHMP also recommended the extension of indications for five previously approved medicines: the H5N1 pandemic influenza vaccine (AstraZeneca), Kyinsu, Talvey, Tryngolza, and Tukysa.
Conversely, for ‘Narsoplimab,’ intended for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, the committee confirmed its previous refusal of marketing authorization following a re-examination. Additionally, applications for expanded cancer indications for Ibrance and Truqap were withdrawn by the respective pharmaceutical companies.
In other developments, the committee recommended changing the legal status of the emergency opioid overdose treatment nasal spray ‘Naloxone’ to non-prescription (OTC) availability. This report is based on the official EMA CHMP announcement, pending final approval from the European Commission (EC).
Official Sources and Meeting Information
This article is based on the results of the official EMA plenary meeting published on October 16, 2026.
- Official Source: EMA CHMP Meeting Highlights (12-15 October 2026)