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Isturisa reimbursement request withdrawn in Portugal; INFARMED publishes public evaluation report

🇵🇹 INFARMED · Wed 21 Oct 2026

The marketing authorisation holder has pulled its prior evaluation request for osilodrostat in endogenous Cushing's syndrome, and INFARMED has posted the public report on Infomed.

Portugal's medicines authority INFARMED has reported that the marketing authorisation holder for Isturisa (osilodrostat) withdrew its request for prior evaluation of the medicine. The notice is dated 21 October 2026.

The request covered one indication: treatment of endogenous Cushing's syndrome in adults. The source does not say why the request was withdrawn, and it gives no information on pricing, the evaluation's findings or any plan to resubmit.

INFARMED said the public report on the evaluation is available on Infomed, on the medicine's own page. It can also be found on the authority's page devoted to funding decisions.

The notice does not mention any safety issue, change to the product information or change to the medicine's regulatory status. It is a market-access update only.

What it means for your team

  • Market-access teams tracking Portuguese reimbursement can find the Isturisa public evaluation report on Infomed and on INFARMED's funding decisions page.
  • The withdrawal covers only the prior evaluation request for endogenous Cushing's syndrome in adults. The source gives no reasons and no next steps.
  • No safety or labelling change is stated, so pharmacovigilance and regulatory teams have no action arising from this notice.

Official source: INFARMED ↗

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

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