Bristol Myers Squibb Canada (BMS) announced that Health Canada has approved SOTYKTU (deucravacitinib tablets), the first-in-its-class oral tablet for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
"Being able to offer an effective, once-daily oral treatment to my patients is extraordinarily exciting. We have so many patients who are looking for a convenient alternative to topical and existing treatments. A once-daily oral treatment has the potential to change the current standard of care and its proven efficacy will improve patients' quality of life," said Dr. Kim A. Papp, MD, Ph.D., FRCPC, President and Founder, Probity Medical Research. "I know my patients face not only significant physical challenges because of their psoriasis, but they also confront mental and daily social challenges due to the nature of their condition."
Psoriasis is a chronic inflammatory condition impacting the lives of nearly a million Canadians across the country. The severity of the condition ranges from dandruff-like scales to patches that cover large areas of skin. Plaque psoriasis is the most common type of psoriasis, most often appearing on elbows and knees, and with over half of patients on their scalps. These patches of affected skin are inflamed and sensitive to the touch, resulting in experiences that impact daily activities such as walking, exercising, going to restaurants or shopping for groceries. Additionally, psoriasis patients often face mental health challenges resulting in issues such as social anxiety, depression and lack of self-esteem.
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor, which works by selectively blocking the activity of the "TYK2" enzyme, which is involved in the process of inflammation. Studies have demonstrated that TYK2 inhibitors are well-tolerated in patients with psoriasis. SOTYKTU helps control inflammation affiliated with psoriasis and helps to reduce symptoms such as itching, pain, burning, stinging, skin tightness, skin plaque, and associated signs. SOTYKTU has been shown to improve quality of life, with the condition having less of an impact on daily activities, relationships, and other factors.
"SOTYKTU has a novel mechanism of action and is the newest oral treatment for psoriasis in nearly eight years. The approval of SOTYKTU reinforces our dedication to patients and our passion for innovation," said Troy André, General Manager, Bristol Myers Squibb Canada. "As our first psoriasis product, we are proud of this milestone and continued legacy of developing and offering innovative therapeutic options to those who need it."
Health Canada's approval of SOTYKTU is based on data from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which evaluated the safety and efficacy of SOTYKTU (6 mg once daily) compared to placebo and apremilast (30 mg twice daily) in patients 18 years of age and older with moderate to severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Both were multi-national, multi-center, randomized, double-blind, placebo- and active comparator-controlled 52-week Phase 3 studies. The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 and the percentage of patients who achieved static Physician's Global Assessment score of 0 or 1 at Week 16 versus placebo.
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