AbbVie’s SKYRIZI™ (risankizumab) Receives First Global Regulatory Approval in Japan for Psoriasis and Psoriatic Arthritis with Once-Every-Three-Months Dosing

March 27, 2019 News /BioonBIOON/ -- U.S. biotechnology giant AbbVie recently announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Skyrizi (risankizumab) 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. Regarding dosing, Skyrizi is administered via subcutaneous injection at a dose of 150 mg (two 75-mg injections) at weeks 0 and 4, followed by once every three months (12 weeks).

This approval also marks the first regulatory approval for Skyrizi globally. Currently, Skyrizi is undergoing regulatory review in the United States and the European Union. In the United States,FDAThe Prescription Drug User Fee Act (PDUFA) goal 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 two to three months.

The MHLW approval of Skyrizi is based on data from Phase II and III clinical studies (sustalMM, ultlMMa-1, and IMMspire) conducted in Japanese adult patients with plaque psoriasis, generalized pustular psoriasis (GPP), and erythrodermic psoriasis, as well as a global Phase II clinical study conducted in adult patients with active psoriatic arthritis.

Michael Severino, President and Vice Chairman of AbbVie, stated, “With the first global approval of Skyrizi, we are pleased to provide a new treatment option for patients with psoriasis in Japan. Skyrizi has the potential to improve the signs and symptoms of these chronic immune-mediated diseases. We look forward to continuing our collaboration with regulatory authorities to enable more patients worldwide to access Skyrizi and benefit from its treatment.”

Psoriasis is a chronic, non-contagious inflammatory disease characterized by inflamed, scaly plaques that often cause itching, burning, and stinging sensations. Psoriasis is associated with several comorbid conditions; in Japan, up to 15% of patients with psoriasis also develop chronic psoriatic arthritis, a chronic inflammatory condition that can lead to irreversible joint deformity and disability. Globally, up to 30% of patients with psoriasis may develop psoriatic arthritis.

The active pharmaceutical ingredient of Skyrizi is risankizumab, a monoclonal antibody that selectively blocks interleukin-23 (IL-23), an immune-inflammatory mediator in the body, 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 a $600 million upfront payment. 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 Pharmaceutical’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. Previously, the pharmaceutical market research firm EvaluatePharma predicted that the drug’s annual sales would reach $2.2 billion in 2024. (Bioon.com)

Original Source:AbbVie Announces First Regulatory Approval of SKYRIZI™ (risankizumab) for the Treatment of Plaque Psoriasis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis and Psoriatic Arthritis in Japan