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Sanofi’s Dupixent (dupilumab) Receives the US FDA’s Approval for the Treatment of Atopic Dermatitis in Children Aged 6 months to 5 years

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Sanofi’s Dupixent (dupilumab) Receives the US FDA’s Approval for the Treatment of Atopic Dermatitis in Children Aged 6 months to 5 years

Sanofi’s Dupixent (dupilumab) Receives the US FDA’s Approval for the Treatment of Atopic Dermatitis in Children Aged 6 months to 5 years

Shots:

  • The US FDA has approved Dupixent for AD in children aged 6mos. to 5yrs. whose disease is not adequately controlled with topical prescription therapies
  • The approval was based on the P-III trial evaluating Dupixent (200/300mg, q4w) with low-potency TCS vs TCS alone in 162 children for 16wks. The trial met the 1EPs & 2EPs i.e., patients achieved clear or almost clear skin (28% vs 4%), ≥75% improvement in overall disease severity from baseline (53% vs 11%), reduction in itch (48% vs 9%)
  • The safety profile was similar to the safety profile in patients aged ≥6yrs. & long-term safety profile from 52wks. OLE trial in children aged 6mos. to 5yrs. was similar to the pivotal trial & consistent with those observed in older patients

Ref: Sanofi | Image: Sanofi 

 

Click here to­ read the full press release 

Neha

Neha is a Senior Editor 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. She can be contacted at connect@pharmashots.com.

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