RegulatoryOfficial

CHMP October 2026: four new medicines backed, including oral GLP-1 Foundayo and RAS inhibitor Rasonque

🇦🇹 BASG · Thu 12 Nov 2026

Austria's BASG summarises the CHMP's 12-15 October meeting, which recommended new products for obesity, type 2 diabetes, pancreatic cancer, glioma and achondroplasia, plus several extensions of indication.

BASG has published its overview of the October 2026 CHMP meeting, listing the new medicines recommended for authorisation and the extensions of indication endorsed. The new recommendations cover weight management, type 2 diabetes, pancreatic cancer, brain tumour and achondroplasia.

Foundayo (orforglipron), an oral GLP-1 receptor agonist, received a positive opinion for weight management in adults with a BMI of at least 30 kg/m², or 27 to under 30 kg/m² with at least one weight-related comorbidity. It was also recommended for adults with insufficiently controlled type 2 diabetes, as monotherapy where metformin is unsuitable or in combination with other diabetes medicines. BASG notes that the EMA has issued a press release.

Rasonque (daraxonrasib) was recommended for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. BASG describes it as a novel RAS inhibitor that binds the active state of the RAS protein, unlike authorised RAS inhibitors that target specific alterations. It holds orphan designation, and the EMA has issued a press release. Yuviwel (navepegritide), a prodrug of C-type natriuretic peptide, was recommended for achondroplasia in children aged 2 years and over whose epiphyses have not closed, with genetic confirmation of diagnosis advised. It also has orphan designation.

Kizfizo (temozolomide) is a hybrid medicinal product referencing Temodal, authorised since 1999, and was recommended for newly diagnosed glioblastoma multiforme in adults and for recurrent or progressive malignant glioma in patients aged one year and over. BASG describes it as a newly formulated oral suspension for paediatric patients aged 1 to 3 years, and it carries orphan designation.

Among extensions of indication, Kyinsu (insulin icodec/semaglutide) was broadened for adults with insufficiently controlled type 2 diabetes; previously patients had to have been treated with a basal insulin or a GLP-1 receptor agonist. The H5N1 AstraZeneca pandemic influenza vaccine (live attenuated, nasal) was extended to active immunisation in an officially declared pandemic situation, having previously been limited to prophylaxis in those aged 1 to 18. Talvey (talquetamab) was extended for use with daratumumab and pomalidomide, or with daratumumab, in relapsed or refractory multiple myeloma; the source text is cut off at that point.

What it means for your team

  • Teams with Kyinsu, Talvey or the H5N1 AstraZeneca vaccine should prepare for product information changes once the extensions are formally adopted.
  • Foundayo, Rasonque, Yuviwel and Kizfizo are new products whose EU launch and risk management planning will need tracking by market-access and PV teams.
  • Kizfizo, as a hybrid of Temodal, is relevant for those monitoring the temozolomide family and paediatric formulation developments.
  • The BASG text is truncated after the Talvey entry, so check the EMA's full meeting highlights for remaining items, including newly published EPARs and started procedures.

Official source: BASG ↗

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

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