PharmacovigilanceOfficial

AIFA's October innovative-medicines update recognises no new products, publishes two negative reports

🇮🇹 AIFA · Tue 03 Nov 2026

Italy's medicines agency found no medicine qualifying for innovative status in the October 2026 review, but released reports on Ezmekly and Pedmarqsi, which both had negative outcomes.

The Italian Medicines Agency (AIFA) updated its list of medicines that the Scientific and Economic Commission (CSE) considers to meet the criterion of therapeutic innovativeness, current to 31 October 2026. It published the update on 3 November. AIFA also makes the evaluation reports for each therapeutic indication available alongside the list.

For the October review period, AIFA says no medicine was granted innovative status. It instead published the report for Ezmekly (mirdametinib), which received a negative result in the innovativeness assessment. The indication assessed is monotherapy for symptomatic, inoperable plexiform neurofibromas in adults and children aged two years and over with neurofibromatosis type 1 (NF1).

AIFA also published the innovativeness report for Pedmarqsi (sodium thiosulfate), which it describes as having had a negative outcome in the evaluation for reimbursability. The indication is prevention of cisplatin-induced ototoxicity in patients from one month to under 18 years of age with localised, non-metastatic solid tumours.

In a separate section on anti-infectives for multidrug-resistant infections, AIFA reports no updates for October. No determinations were published on whether anti-infectives meet the access requirement for the Innovative Medicines Fund.

What it means for your team

  • Market-access teams should note that no product gained innovative status in this cycle. Innovative status in Italy is linked to access and reimbursement benefits.
  • The Ezmekly and Pedmarqsi reports are available for review and may be useful for dossier preparation or benchmarking of future submissions in comparable indications.
  • Anti-infective developers should note there were no new Innovative Medicines Fund access determinations for multidrug-resistant infections this month.
  • The item has no direct pharmacovigilance implications.

Official source: AIFA ↗

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

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