AbbVie’s SKYRIZI (Risankizumab) Approved in Canada for Moderate-to-Severe Plaque Psoriasis with Once-Every-Three-Months Dosing; Projected to Reach $2.2 Billion in Annual Sales by 2024

April 21, 2019 /BioValleyBIOON/ -- U.S. biotechnology giant AbbVie recently announced that Health Canada has approved Skyrizi (risankizumab) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. For dosing, Skyrizi is administered via subcutaneous injection at a dose of 150 mg (two 75 mg injections) at weeks 0 and 4, followed by one dose every 3 months (12 weeks).

This approval is based on data from four pivotal Phase III clinical studies (ultIMMa-1, ultIMMa-2, IMMvent, and IMMhance). These studies enrolled more than 2,000 adult patients with moderate-to-severe plaque psoriasis. The results demonstrated that Skyrizi significantly improved the clearance of psoriatic skin plaques after just 16 weeks of treatment, and maintained plaque clearance over one year (52 weeks) of therapy.

It is worth noting that this approval also marks the second regulatory approval Skyrizi has secured globally. In late March of this year, Skyrizi was approved in Japan for the treatment of adult patients with plaque psoriasis, generalized pustular psoriasis (GPP), erythrodermic psoriasis, and psoriatic arthritis who have had an inadequate response to conventional therapies.

Currently, Skyrizi is also undergoing regulatory review in the United States and the European Union. In the United States,FDAThe Prescription Drug User Fee Act (PDUFA) target date has been set for April 25, 2019. In the European Union, Skyrizi received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in early March this year, with approval expected within the next 2–3 months.

Dr. Melinda Gooderham, a dermatologist at the Peterborough Dermatology Centre in Ontario, stated, “When treating patients with chronic conditions such as psoriasis, having several treatment options is important. Skyrizi offers a safe and simple three-month dosing regimen, providing us with greater opportunities to streamline patient management. As a dermatologist, this allows me to devote more time to other patient-related issues that impact their overall health and well-being.”

The active pharmaceutical ingredient in Skyrizi is risankizumab, a monoclonal antibody that selectively blocks interleukin-23 (IL-23), an immune-inflammatory mediator, by specifically targeting the IL-23p19 subunit. IL-23 is a cytokine believed to play a key role in many chronic immune-mediated diseases. Risankizumab was initially developed by the German pharmaceutical company Boehringer Ingelheim (BI). In February 2016, AbbVie acquired the global commercialization rights to risankizumab through an upfront payment of $600 million. Currently, Skyrizi is in Phase III clinical trials for the treatment of psoriasis, Crohn’s disease, and psoriatic arthritis. Additionally, AbbVie is evaluating risankizumab for the treatment of ulcerative colitis.

Following its market launch, Skyrizi will enter a highly crowded marketplace, where it will compete with multiple drugs, including:NovartisCosentyx and Ilaris,Eli Lillysuch as Eli Lilly’s Taltz, Valeant’s Siliq, Johnson & Johnson’s Tremfya, and Sun Pharma’s Ilumya. Among these drugs, Tremfya and Ilumya are also selective IL-23-targeting biologics. Nevertheless, despite all this competition, the industry remains highly optimistic about Skyrizi’s commercial prospects. EvaluatePharma, a pharmaceutical market research firm, previously predicted that the drug’s annual sales would reach $2.2 billion in 2024. (Bioon.com)

Original source:Health Canada Approves SKYRIZI (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis