🇪🇺 Exdensur in European Union

EMA authorised Exdensur on 12 February 2026

Marketing authorisation

EMA — authorised 12 February 2026

  • Application: EMEA/H/C/006446
  • Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
  • Local brand name: Exdensur
  • Indication: Asthma  Exdensur is indicated as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller (see section 5.1). Chronic rhinosinusitis with nasal polyps (CRSwNP)  Exdensur is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequat
  • Status: approved

Exdensur is a new medicine approved by the European Medicines Agency (EMA) for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps. It is indicated as an add-on treatment for adults and adolescents aged 12 and older with severe asthma who have type 2 inflammation and are not adequately controlled with high-dose inhaled corticosteroids and another asthma controller. Exdensur is also approved for the treatment of severe chronic rhinosinusitis with nasal polyps in adults who have not responded to systemic corticosteroids and/or surgery. The marketing authorisation was granted to GlaxoSmithKline Trading Services Limited on 12 February 2026.

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Exdensur 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 Exdensur approved in European Union?

Yes. EMA authorised it on 12 February 2026.

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

GlaxoSmithKline Trading Services Limited holds the EU marketing authorisation.