GSK’s ultra‑long‑acting IL‑5 biologic Exdensur wins EU approval for severe asthma and CRSwNP | iPharmaCenter

Exdensur (depemokimab), GSK’s new ultra‑long‑acting anti‑IL‑5 biologic, has been granted marketing authorisation by the European Commission for two respiratory indications: severe asthma driven by type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP).

It is the first biologic in the EU that can be used across respiratory diseases with a twice‑yearly dosing schedule, and the approval is supported by four phase III studies – SWIFT‑1, SWIFT‑2, ANCHOR‑1 and ANCHOR‑2 – all of which achieved their primary or co‑primary endpoints with statistically significant and clinically meaningful benefits versus standard care alone.

Under the EC decision, Exdensur is authorised as an add‑on maintenance treatment for adults and adolescents (≥12 years) with severe asthma and type 2 inflammation, defined by elevated blood eosinophils, who remain inadequately controlled on high‑dose inhaled corticosteroids plus at least one other controller, and as an add‑on to intranasal corticosteroids in adults with severe CRSwNP whose disease is not adequately controlled with systemic steroids and/or surgery. Asthma affects over 42 million people in Europe and an estimated 3 million live with a severe form of the disease, while many patients with CRSwNP experience persistent, debilitating symptoms despite current options, underscoring the unmet need Exdensur aims to address.

SWIFT programme: severe eosinophilic asthma

The SWIFT‑1 and SWIFT‑2 phase III trials enrolled patients with severe asthma and an eosinophilic/type 2 phenotype who were already receiving high‑dose ICS plus additional controller therapy. Across both studies, adding depemokimab every six months significantly reduced the annualised rate of severe asthma exacerbations over 52 weeks by 58% (SWIFT‑1) and 48% (SWIFT‑2) versus placebo on top of standard of care, corresponding to exacerbation rates of 0.46 vs 1.11 and 0.56 vs 1.08 events per year, respectively.

In a key secondary analysis, depemokimab‑treated patients had numerically fewer exacerbations requiring hospitalisation and/or emergency department visits (1% and 4% in SWIFT‑1 and SWIFT‑2) than those receiving placebo (8% and 10%), and a prespecified pooled analysis showed a 72% reduction in the annualised rate of clinically significant exacerbations requiring hospital or ED care (rate ratio 0.28).

ANCHOR programme: severe CRSwNP

ANCHOR‑1 and ANCHOR‑2 were phase III, randomised, double‑blind studies in adults with severe CRSwNP who remained uncontrolled despite intranasal steroids and, in many cases, prior systemic corticosteroids and/or sinus surgery. In these trials, depemokimab given twice yearly on top of intranasal corticosteroids led to statistically significant improvements in endoscopic nasal polyp score at week 52, with treatment differences versus placebo of –0.7 in ANCHOR‑1 and –0.6 in ANCHOR‑2 on an 0–8 scale.

Depemokimab also improved patient‑reported nasal obstruction over weeks 49–52, with treatment differences of –0.23 and –0.25 on a 0–3 verbal response scale in ANCHOR‑1 and ANCHOR‑2, respectively, supporting its role in reducing both objective polyp burden and symptoms.

By combining high binding affinity and potency against IL‑5 with an extended half‑life, depemokimab provides sustained suppression of type 2 inflammation with just two doses per year, offering a convenient option for patients whose asthma or CRSwNP remain uncontrolled on existing therapies.

Exdensur has also recently been approved in the US for severe asthma, and has secured marketing authorisations in the UK and Japan for severe asthma and CRSwNP, reinforcing its emerging role as a global, ultra‑long‑acting biologic across type 2 inflammatory airway diseases.