AbbVie’s Skyrizi snatches up FDA approval in moderate to severe plaque psoriasis

pharmafile | April 24, 2019 | News story | Research and Development, Sales and Marketing AbbVie, FDA, Skyrizi, US, pharma, psoriasis 

AbbVie has revealed that its interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab-rzaa) has received marketing authorisation in the US from the FDA in the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

According to the company, Skyrizi produced “high rates of durable skin clearance” in two Phase 3 clinical trials. The approval was based on data which showed that, after 16 weeks, 75% of patients achieved a Psoriasis Area and Severity Index (PASI) score of 90, compared to 5% and 2% of placebo patients. A score of 100 was achieved over the same period by 36% and 51% of participants compared to 0% and 2% of placebo patients.

After one year of treatment, 82% and 81% achieved PASI 90 with Skyrizi, and 56% and 60% achieved PASI 100.

“The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals,” said Dr Kenneth B Gordon, a principal investigator on one of the trials and Professor and Chair of Dermatology at the Medical College of Wisconsin. “In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I’m pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response.”

AbbVie collaborates with Boehringer Ingelheim on Skyrizi, but the former is leading development and commercialisation of the drug around the world.

Psoriasis is the most common autoimmune disease in the US, affecting 7.5 million across the country. Characterised by inflammation and painful, itchy plaques on the skin, those with the condition can experience a significant burden on their quality of life.

“The approval of Skyrizi is an important advance in the treatment of adults with plaque psoriasis who are seeking high levels of durable skin clearance that can be maintained over time,” said Dr Michael Severino, Vice Chairman and President at AbbVie. “Skyrizi builds on AbbVie’s legacy in immunology, expanding our portfolio to help meet the evolving needs in psoriatic disease and reinforcing our continued pursuit of innovations that improve care for people living with immune-mediated conditions.”

Matt Fellows

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