AbbVie's Skyrizi (risankizumab-rzaa) Receives FDA's Approval for Moderate to Severe Plaque Psoriasis
Shots:
- The approval is based on four P-III ultIMMa-1- ultIMMa-2- IMMhance and IMMvent studies results assessing Skyrizi (risankizumab) vs PBO- adalimumab- ustekinumab in patients with moderate to severe plaque psoriasis
- The P-III ultIMMa-1 & ultIMMa-2 result: @16 wks. PASI 90 (75% vs 5% & 2%); PASI 100 (36% & 51% vs 0% & 2%); @52wks. PASI 90 (82% & 81% vs 56% & 60%); @16 wks. integrated results showed maintenance of PASI 90 and PASI 100 for 1yr. (88% & 80%) respectively
- Skyrizi (risankizumab-rzaa) is an IL-23 inhibitor that works by binding to p19 subunit- administered four doses/yr. after two initial doses and has received MHLW approval for plaque psoriasis- Health Canada approval and EMA’s CHMP positive opinion for moderate-to-severe plaque psoriasis with its expected regulatory decision in EU and availability in the US in H1’19 & May’19 respectively
Ref: Abbvie | Image: Pharmaceutical Technology
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