The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s allosteric tyrosine kinase 2 inhibitor Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis.
It is approved in patients who are candidates for systemic therapy or phototherapy, but not recommended in combination with other potent immunosuppressants.
In the Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials, once-daily Sotyktu showed superior efficacy to placebo and twice-daily Otezla (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis.
“Sotyktu has the potential to become the new standard of care oral treatment for people with moderate-to-severe plaque psoriasis,” said April Armstrong, MD, MPH, clinical investigator in the POETYK PSO-1 trial and Associate Dean and Professor of Dermatology at the University of Southern California.
Psoriasis is a widely prevalent, immune-mediated disease that affects approximately 7.5 million people in the US, of which, up to 90% have plaque psoriasis.
Bristol Myers Squibb has also reported positive results from the POETYK PSO long-term extension (LTE) trial, demonstrating clinical efficacy was maintained for two years of continuous treatment.
“The reality we are facing is that dermatologists and individuals with psoriasis alike have identified the need for more effective and tolerable oral therapies, as psoriasis is a chronic, systemic, immune-mediated disease that is associated with serious comorbidities,” added Dr Mark Lebwohl, MD, Dean of Clinical Therapeutics at the Kimberly and Eric J Waldman Department of Dermatology at the Icahn School of Medicine, Mount Sinai (New York).
Sotyktu is expected to be available to patients in the US in September 2022.