Bristol Myers Squibb (BMY) announced that the U.S. Food and Drug Administration has approved Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA). This marks the first approval of a selective tyrosine kinase 2 (TYK2) inhibitor for PsA.
The FDA's decision was based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 trials, which evaluated the efficacy and safety of Sotyktu 6 mg once daily in adults with active psoriatic arthritis. In both studies, patients treated with Sotyktu showed significant improvement in disease activity, measured by the American College of Rheumatology 20 (ACR20) response as the primary endpoint, and Minimal Disease Activity (MDA) response as a key secondary endpoint.
Sotyktu was first approved in 2022 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is not recommended for use with other potent immunosuppressants in this population. Since its initial approval, multiple global regulatory authorities have also cleared Sotyktu for plaque psoriasis. The drug now has five years of clinical efficacy and safety data supporting its use in patients with moderate-to-severe plaque psoriasis.
BMY closed at $60.29 on March 6, down $0.45 or 0.74%. In after-hours trading, the stock slipped further to $60.01, a decline of $0.28 or 0.46%.
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