FDA approved Bristol-Myers Squibb Company (BMY.US) TYK2 inhibitor Deucravacitide for the treatment of active psoriatic arthritis in adult patients.

Bristol-Myers Squibb Company (BMY.US) announced that the U.S. Food and Drug Administration (FDA) has approved Breyzelda (deucravacitinib) for the treatment of adult patients with active psoriatic arthritis (PsA). Breyzelda is an oral selective tyrosine kinase 2 (TYK2) inhibitor and is the first TYK2 inhibitor approved for the treatment of PsA. The FDA approval was based on the positive results of the pivotal POETYK PsA-1 and POETYK PsA-2 trials. Both studies evaluated the efficacy and safety of Breyzelda (6mg, once daily) in adult patients with active psoriatic arthritis. In these studies, treatment with Breyzelda led to significant improvement in disease activity, as assessed by measures including the American College of Rheumatology (ACR)20 response (primary endpoint) and minimal disease activity (MDA) response (key secondary endpoint). Data shows that in 2022, the FDA first approved Breyzelda for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Since then, multiple regulatory agencies worldwide have also approved Breyzelda for this indication. Breyzelda has accumulated 5 years of clinical efficacy and safety data in the treatment of moderate to severe plaque psoriasis.