Shots:
- FDA has approved GSK’s Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with an eosinophilic phenotype following MHRA’s approval for both asthma & CRSwNP; regulatory review is ongoing in EU, Japan & China
- Approval was based on the P-III trials: SWIFT-1 (n=382) & SWIFT-2 (n=380) assessing Exdensur vs PBO, both in addition to SoC, which showed twice yearly Exdensur reduced annualised asthma exacerbations, achieving 58% & 48% reductions, respectively, over 52wks.
- Exdensur also reduced hospitalisation or emergency department-treated exacerbations vs PBO (SWIFT-1: 1% vs 8% SWIFT-2: 4% vs 10%), with a pooled analysis showing a 72% decrease in annualised hospitalization-requiring events over 52wks.
Ref: GSK | Image: GSK | Press Release
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