Regeneron and Sanofi’s Dupixent (dupilumab) Receive the US FDA’s Approval as an Add-On Maintenance Treatment to Treat Moderate-To-Severe Asthma

October 21, 2021 Auto Bot approval, Asthma, dupilumab, Dupixent, FDA, Regeneron, regulatory, Sanofi 0

Shots:

  • The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma
  • The results showed a 65% avg. reduction in the rate of severe asthma attacks @1yrs.; improvement in lung function by 5.32% points @ 12wks. & as early as 2wks. & sustained for ~52wks, improved asthma control @24wks.; improvement on disease symptoms & impact (81% vs 64%) as measured by ≥0.5 improvements on a 7-point scale
  • The safety results were consistent with the known safety profile of Dupixent in patients aged ≥12yrs. The therapy is currently under regulatory review in the EU & other authorities globally for children aged 6 to 11yrs.

click here ­to­ read full press release/ article | Ref: PRNewswire| Image: Sanofi

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