The European Medicines Agency's human medicines committee, the CHMP, recommended six new medicines for EU approval at its meeting of 12-15 October 2026, including Eli Lilly's once-daily oral GLP-1 pill Foundayo (orforglipron) and Revolution Medicines' pancreatic cancer tablet Rasonque (daraxonrasib). It also backed five extensions of indication and confirmed one refusal.
The outcomes were published in the agency's meeting highlights on 16 October 2026. These are committee opinions, not approvals. The European Commission makes the legally binding decision, normally within 67 days of a CHMP opinion, and every medicine on the October list is marked "pending EC decision". Price and reimbursement are then decided nationally.
- Six new medicines: Foundayo, Rasonque, Yuviwel, Kizfizo and two biosimilars, Fovlussea and Neuzafy.
- Obesity and diabetes: Foundayo would be the second oral GLP-1 medicine for weight management in the EU, after Novo Nordisk's Wegovy pill.
- Pancreatic cancer: Rasonque was reviewed in phases as a high-priority medicine under EMA's Cancer Medicines Pathfinder.
- Rare diseases: Yuviwel (achondroplasia) and Kizfizo (glioma) both hold orphan designations.
- Refusal confirmed: Omeros Ireland Limited's Yartemlea (narsoplimab) was again turned down after re-examination.
- Extensions: five already-authorised medicines, including AstraZeneca's H5N1 pandemic influenza vaccine, were recommended for new uses.
The six new medicines
The committee issued no negative opinions on new medicines this month. The six positive opinions are set out below, using the applicant named by EMA.
| Medicine (company) | Recommended for |
|---|---|
| Foundayo, orforglipron (Eli Lilly) | Weight management and type 2 diabetes in adults; oral, once daily |
| Rasonque, daraxonrasib (Revolution Medicines) | Metastatic pancreatic cancer in adults who have had at least one previous treatment |
| Yuviwel, navepegritide (Ascendis Pharma) | Achondroplasia in children; orphan medicine |
| Kizfizo, temozolomide (Orphelia Pharma) | Glioblastoma multiforme in adults and malignant glioma in children; hybrid application, orphan medicine |
| Fovlussea, ranibizumab (Accord Healthcare) | Biosimilar for neovascular (wet) age-related macular degeneration and other retinal conditions that impair vision |
| Neuzafy, filgrastim (CuraTeQ Biologics) | Biosimilar for neutropenia in adults and children |
Foundayo: an oral GLP-1 for weight and diabetes
Orforglipron is a small, non-peptide molecule that activates the GLP-1 receptor. PharmExec notes that it can be taken at any time of day without food or water restrictions.
EMA's assessment of weight management drew on two studies in more than 4,740 adults with obesity or overweight. After 72 weeks, people taking Foundayo lost about 5-11% of their body weight, depending on dose, compared with about 2-2.5% on placebo. In type 2 diabetes, four studies in 3,765 adults showed HbA1c falls of roughly 1.2-1.9 percentage points, with placebo, dapagliflozin and oral semaglutide as comparators. The most common side effects were nausea, vomiting and diarrhoea.
If the Commission follows the opinion, Foundayo would become the second oral GLP-1 medicine authorised for weight management in the EU, after Novo Nordisk's Wegovy pill, which was approved in July for weight management only, pharmaphorum reported. The US Food and Drug Administration approved Foundayo for obesity in April 2026.
Rasonque: a RAS-targeted tablet for pancreatic cancer
Rasonque was reviewed under a phased process after EMA identified it as a high-priority medicine under its Cancer Medicines Pathfinder. Revolution Medicines said the recommended indication covers adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, as a once-daily oral tablet given on its own.
The opinion rests on the Phase 3 RASolute 302 trial, which compared daraxonrasib with the investigator's choice of chemotherapy. In the intention-to-treat population, the company reported a hazard ratio for overall survival of 0.40 (95% CI 0.30-0.53), with median overall survival of 13.2 months against 6.7 months, and median progression-free survival of 7.2 months against 3.6 months.
"Today's positive CHMP opinion marks a major step toward making RASONQUE available," said Mark A. Goldsmith, Chief Executive Officer and Chairman of Revolution Medicines. The FDA approved the medicine in August 2026.
Yuviwel, Kizfizo and the two biosimilars
Yuviwel is a once-weekly injection of navepegritide, a C-type natriuretic peptide analogue. Ascendis Pharma said the recommendation covers children aged two years and older whose growth plates are still open. In its pivotal ApproaCH trial of 84 children aged two to 11, annualised growth velocity at week 52 was 5.89 cm a year on navepegritide and 4.41 cm a year on placebo. Ascendis expects a Commission decision in the fourth quarter of 2026 and plans to launch first in Germany in early 2027.
Kizfizo, from Orphelia Pharma, is a hybrid application for the chemotherapy temozolomide, meaning it relies partly on data from an already-authorised reference medicine. EMA did not name that reference product, or those for the two biosimilars, Fovlussea and Neuzafy.
Yartemlea refusal confirmed
The committee confirmed its June recommendation to refuse a marketing authorisation for Yartemlea (narsoplimab), an orphan medicine intended for thrombotic microangiopathy associated with haematopoietic stem cell transplantation in patients aged two and over. The applicant was Omeros Ireland Limited.
According to EMA's page on the medicine, the company "did not provide sufficient evidence of the effectiveness of Yartemlea". The main study had no placebo or comparator group, and a conditional authorisation was ruled out because "the benefits of the medicine are not demonstrated". On re-examination, EMA found the earlier concerns still unresolved.
Five extensions of indication
The CHMP recommended new uses for five medicines already authorised in the EU: Pandemic influenza vaccine H5N1 AstraZeneca; Novo Nordisk's Kyinsu (insulin icodec and semaglutide); Janssen's Talvey (talquetamab) for multiple myeloma; Sobi's Tryngolza (olezarsen), which pharmaphorum said is recommended alongside other lipid-lowering therapies for severe hypertriglyceridaemia; and Pfizer's Tukysa (tucatinib) for HER2-positive breast cancer. EMA's highlights page lists the five medicines but does not set out the new indication wording for each, including for the H5N1 vaccine. Separately, the committee recommended that Nyxoid, a naloxone nasal spray, become available without a prescription.
Why it matters for Ireland
A centralised EU authorisation covers Ireland automatically, so these opinions set the pipeline of medicines that could become available here. Access in practice depends on companies launching in Ireland and on HSE pricing and reimbursement decisions, which follow separately. The Yartemlea refusal involved an Irish-registered applicant, Omeros Ireland Limited. Follow decisions on our EMA approvals tracker and worldwide drug approvals page, or related studies in European clinical trials.
Frequently Asked Questions (FAQ)
Q: Is Foundayo now approved in the EU?
A: Not yet. The CHMP recommended approval on 15 October 2026. The European Commission must now adopt a decision before the medicine can be marketed in the EU.
Q: How many medicines did the CHMP recommend in October 2026?
A: Six new medicines and five extensions of indication. There were no negative opinions on new medicines, and one refusal, for Yartemlea, was confirmed after re-examination.
Q: Why was Rasonque reviewed differently?
A: EMA identified it as a high-priority medicine under its Cancer Medicines Pathfinder and assessed the data in phases.
Conclusion and Outlook
October's meeting adds a second oral GLP-1 option for weight management, a new targeted treatment for previously treated pancreatic cancer and two orphan medicines to the EU pipeline. The next step is the Commission's decisions, expected over the coming weeks, followed by national pricing and reimbursement, which will decide when and how these medicines reach Irish patients.
Cover image: AI-generated illustration of a pharmaceutical regulatory review meeting. It does not show any real person, product or organisation.
Sources
- European Medicines Agency, Meeting highlights from the CHMP, 12-15 October 2026, 16 October 2026
- European Medicines Agency, Yartemlea: refusal of marketing authorisation
- Revolution Medicines, RASONQUE (daraxonrasib) receives positive CHMP opinion, 15 October 2026
- PharmExec, EMA panel backs Lilly's Foundayo for obesity and type 2 diabetes in Europe, 16 October 2026
- pharmaphorum, CHMP backs Lilly's oral GLP-1 Foundayo for EU approval, October 2026
- Ascendis Pharma, positive CHMP opinion for navepegritide (TransCon CNP), press release, 16 October 2026
