Regeneron and Sanofi’s Dupixent (dupilumab) Receive EC’s Approval for Children with Severe Asthma with Type 2 Inflammation
Shots:
- The approval was based on the P-III (LIBERTY ASTHMA VOYAGE) trial evaluating Dupixent (100/200mg, q2w) + SoC vs PBO in 408 children aged 6 to 11yrs. as an add-on maintenance treatment with sev. asthma
- The results showed a 65% vs 59% avg. reduction in rate of sev. asthma attacks @1yrs.; improvement in lung function by 5.32% vs 5.21% points @ 12wks. & as early as 2wks. & sustained for ~52wks., improved asthma control (81% & 79%) vs (64% & 69%) based on disease symptoms & impact @24wks.; improved health-related QoL (73% & 73%) vs (63% & 65%)
- Additionally, reduction in systemic corticosteroid use (66% vs 59%) @1yr. & safety results were consistent with a known safety profile of Dupixent, AEs (83% vs 80%)
Ref: PR Newswire | Image: Regeneron
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