Bristol Myers Squibb’s sNDA for Sotyktu accepted for review across four regions globally

Bristol Myers Squibb has recently announced that the U.S. FDA has accepted for review the supplemental New Drug Application for Sotyktu  for the treatment of adults with active psoriatic arthritis. This latest regulatory milestone is in addition to the sNDA acceptances by China’s Center for Drug Evaluation of National Medical Products Administration and Japan’s Ministry of Health, Labour and Welfare for Sotyktu for the treatment of adults with active psoriatic arthritis.

“There is a significant need for additional oral treatments for individuals living with psoriatic arthritis, and today’s announcement brings us one step closer to bringing Sotyktu to these patients,” said Roland Chen, MD, Senior Vice President, Drug Development, Immunology and Cardiovascular, Bristol Myers Squibb. “We are eager to continue conversations with the FDA and other global regulatory bodies with the goal of including Sotyktu as a differentiated, first-line, advanced systemic treatment option for psoriatic arthritis, while we pioneer research of this novel molecule in other severe rheumatic conditions.”

Note that Sotyktu received approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Since then they have earned approvals for this indication from multiple global health authorities and demonstrated durable efficacy and a consistent safety profile over more than 20,000 patient-years of experience.

Note that the regulatory applications are based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 trials, which evaluated the efficacy and safety of Sotyktu in adults with active psoriatic arthritis. Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving ACR20 response after 16 weeks of treatment compared with placebo.

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