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AEMPS bulletin flags CHMP October opinions for orforglipron, daraxonrasib and navepegritide

🇪🇸 AEMPS · Fri 06 Nov 2026

Spain's medicines agency has published its October 2026 CHMP bulletin, listing three positive opinions for new medicines and five changes to products already authorised in the EU.

The Spanish Agency for Medicines and Health Products (AEMPS) has published its bulletin on the October 2026 meeting of the EMA's Committee for Medicinal Products for Human Use (CHMP). The document is aimed at healthcare professionals and picks out the opinions the agency considers most relevant.

Three new medicines received positive opinions. They are Foundayo (orforglipron) film-coated tablets in strengths from 0.8 mg to 17.2 mg, Rasonque (daraxonrasib) film-coated tablets at 100 mg and 150 mg, and Yuviwel (navepegritide) powder and solvent for solution for injection at 1.3 mg, 2.8 mg and 5.5 mg.

For Foundayo, the bulletin sets out two indications. The first is weight management, including weight loss and maintenance, alongside a healthy diet and physical activity. It covers adults with a baseline BMI of at least 30 kg/m², or 27 to under 30 kg/m² with at least one weight-related comorbidity. The second is type 2 diabetes in adults whose disease is not sufficiently controlled, as monotherapy when metformin is considered inappropriate or in combination with other diabetes medicines. The bulletin text available is cut off partway through the Foundayo entry, so the indication details for Rasonque and Yuviwel are not visible.

The bulletin also lists changes to indications for five authorised products: Kyinsu (insulin icodec/semaglutide) in a pre-filled pen, AstraZeneca's pandemic H5N1 influenza vaccine as a nasal spray, Talvey (talquetamab), Tryngolza (olezarsen) and Tukysa (tucatinib). The details of those changes are not included in the available text.

AEMPS stresses that these are CHMP scientific opinions issued before European Commission authorisation and market launch, which it says will follow in some months. Once the marketing process begins in Spain, product information, prescribing conditions and actual availability will be published in the agency's CIMA database.

What it means for your team

  • Regulatory teams can treat these opinions as the start of the roughly months-long run-up to Commission decisions, and plan labelling and national-procedure work accordingly.
  • Pharmacovigilance teams should note Foundayo's dual obesity and type 2 diabetes indications when planning risk management and monitoring.
  • Market-access teams should watch CIMA for Spanish product information, prescribing conditions and availability once marketing starts, as these are not yet confirmed.
  • The five extensions of indication, including Talvey, Tryngolza and Tukysa, will need label updates once the Commission decisions are issued; full details should be checked in EMA documents.

Official source: AEMPS ↗

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

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