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Regeneron and Sanofi’s Dupixent (dupilumab) Receive EC’s Approval for Children with Severe Asthma with Type 2 Inflammation

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Regeneron and Sanofi’s Dupixent (dupilumab) Receive EC’s Approval for Children with Severe Asthma with Type 2 Inflammation

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

Click here to­ read the full press release 

Neha

Neha Madan is a content writer at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.

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