EMA Panel Backs Six New Medicines, Including First Oral GLP-1 for Weight Management

EMA Panel Backs Six New Medicines, Including First Oral GLP-1 for Weight Management

The European Medicines Agency's human medicines committee recommended six new medicines for approval at its October 2026 meeting, including Foundayo (orforglipron), an oral GLP-1 receptor agonist for weight management and type 2 diabetes, and Rasonque (daraxonrasib) for metastatic pancreatic cancer. The Committee for Medicinal Products for Human Use (CHMP) also backed five extensions of therapeutic indications and confirmed its refusal of Yartemlea (narsoplimab), according to the meeting highlights published by the European Medicines Agency (EMA).

Key facts

What did the committee recommend for cancer and rare diseases?

The CHMP gave a positive opinion for Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one previous treatment. The recommendation followed a phased review of data, as Rasonque was identified as a high-priority medicine under EMA's Cancer Medicines Pathfinder project, which targets unmet medical needs.

Kizfizo (temozolomide) was recommended for adults with glioblastoma multiforme, an aggressive brain tumour, and for children with malignant glioma. It was submitted as a hybrid application, relying partly on results from an already-authorised reference product and partly on new data.

Yuviwel (navepegritide) was recommended for children with achondroplasia, an inherited disease caused by a mutation in the fibroblast growth-factor receptor 3 gene that affects bone growth and results in very short stature. Two biosimilars also received positive opinions: Fovlussea (ranibizumab) for several eye conditions including neovascular age-related macular degeneration and diabetic macular oedema, and Neuzafy (filgrastim) for neutropenia in adults and children. What about the oral weight-management medicine?

Foundayo (orforglipron) is an oral GLP-1 receptor agonist for weight management and treatment of type 2 diabetes in adults. It will be available as a once-daily tablet, offering an alternative to injectable and other oral GLP-1 receptor agonists. The recommendation is a marketing authorisation, which, if granted by the European Commission, would make it the first oral GLP-1 receptor agonist approved in the EU for these uses. Which applications were refused or withdrawn?

After a re-examination of its initial opinion, the CHMP confirmed its recommendation to refuse marketing authorisation for Yartemlea (narsoplimab). The medicine was intended for adults and children from two years of age with haematopoietic stem cell transplant (HSCT)-associated thrombotic microangiopathy, a serious and potentially life-threatening complication following HSCT.

Two applications to extend the use of existing medicines were withdrawn. Ibrance (palbociclib) was withdrawn for maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer. Truqap (capivasertib) was withdrawn for metastatic prostate cancer that responds to hormone treatment when cancer cells lack a protein called PTEN. What other decisions were taken?

The CHMP finalised its assessment of an application to extend the use of Mylotarg (gemtuzumab ozogamicin) to include children aged one to less than 18 years with newly diagnosed acute myeloid leukaemia (AML). Although the committee did not recommend this use, it agreed that relevant data from the study submitted with the application be included in the medicine's product information so that healthcare professionals have access to up-to-date data on the effects of Mylotarg in these patients.

The committee also recommended changing the legal status of Nyxoid (naloxone) to make it available without a medical prescription. Nyxoid is a nasal spray used for emergency treatment in case of known or suspected overdose of opioid drugs, such as heroin or morphine. What happens next?

The CHMP's recommendations will now be sent to the European Commission for a final decision on marketing authorisations. The agenda of the October 2026 CHMP meeting is published on EMA's website, and the minutes of the meeting will be published in the coming weeks. In 2026 so far, the CHMP has issued 72 positive opinions on new medicines and 8 negative opinions, along with 9 positive opinions on extensions of therapeutic indications.

Source: European Medicines Agency

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