🇪🇺 Brinsupri in European Union

EMA authorised Brinsupri on 18 November 2025

Marketing authorisation

EMA — authorised 18 November 2025

  • Application: EMEA/H/C/005820
  • Marketing authorisation holder: Insmed Netherlands B.V.
  • Local brand name: Brinsupri
  • Indication: Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
  • Pathway: PRIME
  • Status: approved

The EMA approved Brinsupri on 18 November 2025, for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. This approval was granted under the PRIME expedited pathway. Brinsupri is marketed by Insmed Netherlands B.V. under the local brand name Brinsupri.

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Brinsupri in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Respiratory approved in European Union

Frequently asked questions

Is Brinsupri approved in European Union?

Yes. EMA authorised it on 18 November 2025.

Who is the marketing authorisation holder for Brinsupri in European Union?

Insmed Netherlands B.V. holds the EU marketing authorisation.