Shots:
- The MHLW has approved Sanofi and Regeneron’s Dupixent for the treatment of bronchial asthma in children (6-11yrs.) with severe or refractory disease whose symptoms are inadequately controlled with existing therapy
- Approval was based on the P-III (VOYAGE) trial data in the overall population & those with a type 2 inflammation phenotype, which showed reduced severe exacerbations by 54% to 65% & improved lung function by 4.68% to 5.32%
- Approval was further supported by EXCURSION, an OLE of VOYAGE, which included a sub-study in Japanese pediatric pts, showing improved lung function at 12 wks. & a low rate of severe asthma exacerbations over 1yr.
Ref: Sanofi | Image: Sanofi & Regeneron | Press Release
Related News: Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)
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