Novartis’ Cosentyx (secukinumab) Receives the US FDA’s Approval for the Treatment of Moderate to Severe Plaque Psoriasis

June 2, 2021 Auto Bot Cosentyx, FDA, Moderate, Novartis, Plaque Psoriasis, regulatory, Severe 0

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

Click here to­ read full press release/ article | Ref: PRNewswire | Image: BioProcess International

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