New drugs, October decisions by Ema and Aifa

The Committee for Medicinal Products for Human Use of the European Medicines Agency (Chmp) adopted positive opinions for the approval of six new medicines and for the extension of indications of five other medicines already authorised in the European Union, at its October 2026 meeting. This is reported consistently by FarmaciaVirtuale and RIFday, both based on the official Chmp statement.

Among the recommended medicines is Rasonque (active substance daraxonrasib), indicated for adult patients with metastatic pancreatic adenocarcinoma previously treated with other therapies. The committee also recommended indication extensions for AstraZeneca’s pandemic H5N1 influenza vaccine and for Novo Nordisk’s insulin Kyinsu.

At the same time, Aifa’s Board of Directors approved in October 2026 the reimbursement of an orphan drug, the extension of six already authorised therapeutic indications, and the green light for three generic drugs, according to the agency’s statement reported by FarmaciaVirtuale.

The measure concerns in particular Voranigo (active substance vorasidenib), described as the first oral therapy available for patients aged 12 years and older with grade 2 astrocytoma or oligodendroglioma carrying an Idh1 or Idh2 mutation: two genetic variants associated with this type of slow-growing brain tumour.

The two decisions — the European one by the Chmp and the Italian one by Aifa — concern distinct bodies with different competences: the European scientific committee recommends marketing authorisation at EU level, while Aifa separately decides the reimbursement conditions on national territory for already authorised medicines. These are two distinct regulatory phases of the path that takes a medicine from scientific approval to actual availability for patients within the healthcare system.

For both measures, the available sources are official statements from the respective regulatory agencies: detailed clinical efficacy data beyond the authorised therapeutic indications are not currently available, nor is information on the timing of actual availability of the drugs for patients.