AbbVie, Boehringer Ingelheim's IL-23 inhibitor Skyrizi gains US approval for plaque psoriasis

AbbVie announced that the FDA approved Skyrizi (risankizumab-rzaa) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Japanese regulators handed the IL-23 inhibitor its first clearancelast month, while the drug, which is being developed with Boehringer Ingelheim, is also authorised in Canada.

"The approval of Skyrizi is an important advance in the treatment of adults with plaque psoriasis," remarked Michael Severino, president of AbbVie, adding that the therapy "builds on AbbVie's legacy in immunology." Skyrizi, which is administered by two subcutaneous injections every 12 weeks following two initiation doses at week zero and four, is expected to be available in the US in early May.

AbbVie noted that FDA approval of Skyrizi was based on data from the Phase III ultIMMa-1 and ultIMMa-2 studies, with results showing that at 16 weeks, at least a 90-percent reduction in the Psoriasis Area and Severity Index (PASI) was achieved in 75 percent of people treated with the drug, compared to 5 percent and 2 percent receiving placebo, respectively. Meanwhile, PASI 100 was achieved in 36 percent and 51 percent of people treated with Skyrizi, versus 0 percent and 2 percent for placebo, respectively.

In 2016, AbbVie paid $595 million upfront as part of a licensing agreement with Boehringer Ingelheim to develop and commercialise Skyrizi. Under the deal, AbbVie is leading development of the drug, with late-stage studies currently ongoing in Crohn's disease and psoriatic arthritis.

By: Matthew Dennis

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