Shots:

• The approval is based on two P-III studies evaluating Cosentyx (75 mg/ 150 mg) vs PBO in children aged 6 to <18 yrs with plaque psoriasis
• The first study demonstrates reduction in psoriasis severity @12 wks.- PASI 75 response for 75mg and 150mg (55%- 86% vs 10%- 19%)- achieved clear or almost clear skin response (32% - 81% vs 5%- 5%) . The safety profile in both trials was consistent with the safety profile and no new safety signals were identified
• The therapy marks the first FDA approval in a pediatric population in the US and clinical profile is supported by 5 ys of clinical data in adults that showed long-term safety and efficacy across PsO- PsA- and AS

  Ref: PRNewswire | Image: Novartis