Exdensur (depemokimab)
- Region
- 🇪🇺 EU
- Active substance
- depemokimab
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Asthma; Nasal Polyps
- CHMP opinion
- Thu 11 Dec 2025
- EU approval
- Thu 12 Feb 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006446
- ATC
- R03DX12
- Official record
- www.ema.europa.eu
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 adequate disease control.
Regulatory milestones
Exdensur (depemokimab) approved in the EU
Marketing authorisation to GlaxoSmithKline Trading Services Limited; Additional monitoring · source
FDA approves Exdensur (depemokimab-ulaa), a new medicine
Glaxosmithkline Llc; BLA761458; New biologic; injection · source
Exdensur (depemokimab): CHMP positive opinion
GlaxoSmithKline Trading Services Limited; Additional monitoring · source
Same substance in other markets
- 🇺🇸 Exdensur Approved · Glaxosmithkline Llc
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.