RegulatoryOfficial

CHMP October meeting backs six new medicines, including oral GLP-1 orforglipron and pancreatic cancer drug

🇨🇿 SÚKL · Fri 23 Oct 2026

EMA's human medicines committee recommended six products for approval, confirmed a refusal for narsoplimab and backed over-the-counter status for Nyxoid, according to SÚKL's summary.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended six medicines for marketing authorisation at its 12–15 October 2026 meeting, the Czech regulator SÚKL reported on 23 October. The opinions now go to the European Commission for a final decision.

Rasonque (daraxonrasib) received a positive opinion for adults with metastatic pancreatic adenocarcinoma who have had at least one prior treatment. EMA reviewed its data on a rolling basis and had designated it a high-priority medicine under the Cancer Medicines Pathfinder initiative. Foundayo (orforglipron), an oral once-daily GLP-1 receptor agonist tablet, was recommended for weight management and type 2 diabetes in adults. Yuviwel (navepegritide) was backed for achondroplasia in children.

The committee also endorsed two biosimilars: Fovlussea (ranibizumab) for several retinal conditions, including neovascular age-related macular degeneration, and Neuzafy (filgrastim) for neutropenia in adults and children. Kizfizo (temozolomide) was recommended for adults with glioblastoma multiforme and children with malignant glioma. Its application was a hybrid one, relying partly on data from an already authorised reference product and partly on new data.

CHMP recommended extensions of indication for five authorised products: Pandemic influenza vaccine H5N1 AstraZeneca, Kyinsu, Talvey, Tryngolza and Tukysa. After re-examination, it confirmed its earlier recommendation to refuse authorisation for Yartemlea (narsoplimab), proposed for transplant-associated thrombotic microangiopathy after haematopoietic stem cell transplantation in adults and children from two years of age.

Two extension applications were withdrawn: Ibrance (palbociclib) for maintenance therapy in HR-positive, HER2-positive locally advanced or metastatic breast cancer, and Truqap (capivasertib) for hormone-sensitive metastatic prostate cancer lacking the PTEN protein. For Mylotarg (gemtuzumab ozogamicin), the committee did not recommend use in children aged one to under 18 with newly diagnosed acute myeloid leukaemia, but agreed that relevant study data should be added to the product information. It also recommended that Nyxoid (naloxone) nasal spray, used for suspected opioid overdose, be available without prescription. The meeting minutes are due in the coming weeks.

What it means for your team

  • Add the six positive opinions to pipeline trackers and watch for European Commission decisions, which follow CHMP opinions.
  • Teams with products in the extension pipeline should note the five recommended indication extensions and the two withdrawals (Ibrance, Truqap).
  • Biosimilar and hybrid-route approvals (Fovlussea, Neuzafy, Kizfizo) are relevant for competitor and market-entry monitoring.
  • The Nyxoid change in supply status and the confirmed Yartemlea refusal may affect access planning; the full minutes are still to come.

Official source: SÚKL ↗

Article written by VigiEye from the official source (SÚKL). AI-assisted; check the source before acting.

More Regulatory All →