Sotyktu accepted for review in psoriatic arthritis

[Fred]

Bristol Myers Squibb today announced that the U.S. Food and Drug Administration and The European Medicines Agency has accepted for review the supplemental new drug application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis.

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The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026. 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. The European Medicines Agency has also validated Bristol Myers Squibb's Type II variation application to expand the indication for Sotyktu to include this disease.

“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, 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.”

Sotyktu received approval from the FDA in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Since then, Sotyktu has 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.

Sotyktu, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, has the potential to be the first TYK2 inhibitor for the treatment of psoriatic arthritis.

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 (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo. Additional data from POETYK PsA-2 reported outcomes through 52 weeks of treatment and demonstrated that clinical response improved and was maintained from Weeks 16 to 52.

The overall safety profile of Sotyktu through 16 weeks of treatment in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with that established in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials; no new safety signals were observed.

Source: bms.com

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