AbbVie’s Skyrizi scoops up CHMP recommendation for moderate to severe plaque psoriasis

pharmafile | March 4, 2019 | News story | Sales and Marketing AbbVie, pharma, psoriasis 

AbbVie’s interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) has secured recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP), it has emerged.

Specifically, the drug has been recommended for the treatment of moderate to severe plaque psoriasis in adults who are eligible for systemic therapy.

The ruling was based on Phase 3 data derived from over 2,000 participants over four trials. In these studies, Skyrizi met all of its co-primary and ranked secondary endpoints and demonstrated “significantly higher” response of clear or almost clear skin between Week 16 and 52 compared to ustekinumab, adalimumab and placebo, according to the Psoriasis Area and Severity Index.

“Plaque psoriasis can have a significant physical, psychological and social burden on people living with the condition,” explained Dr Michael Severino, Vice Chairman and President at AbbVie. “We are excited that the CHMP has recognised risankizumab’s potential to significantly reduce the signs and symptoms of psoriasis and provide an improved quality of life. In clinical studies, risankizumab demonstrated consistently high rates of skin clearance with a favourable benefit/risk profile. This is an important regulatory milestone in our relentless pursuit of innovative therapies that address unmet needs for patients with serious dermatological conditions.”

AbbVie noted that it expects a final decision on approval from the European Commission within 64 days.

Matt Fellows

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