Bristol Myers Wins FDA Approval for Sotyktu for Psoriatic Arthritis

Bristol Myers Squibb Company (NYSE:BMY) on Friday won U.S. approval for its oral drug Sotyktu to treat adults with active psoriatic arthritis. The decision gives patients another option for joint and skin symptoms tied to the autoimmune disease. The U.S. Food and Drug Administration approved the drug after reviewing late-stage trial data that showed better disease control than placebo, according to a PRNewswire release. The treatment works by selectively targeting tyrosine kinase 2, a pathway involved in immune-driven inflammation. Clinical Trial Results Researchers tested the drug in two global Phase 3 studies, POETYK PsA-1 and POETYK PsA-2. Patients received either a daily 6-milligram tablet or placebo during the controlled part of the trials. Investigators used American College of Rheumatology response criteria to measure results. By Week 16, about 54% of patients taking Sotyktu achieved an ACR20 response in both studies. By comparison, 34% and 39% of placebo patients reached that mark. The gap showed a statistically significant benefit for the treatment group. Other measures also favored the drug. About one-quarter of treated patients achieved an ACR50 response in the two studies. Researchers also saw meaningful gains in minimal disease activity scores. Those results suggested broader relief across joints, skin and patient-reported pain. Expert And Company Commentary “Today’s announcement marks the introduction of a new, differentiated option to treat adults with active psoriatic arthritis,” said Al Reba, senior vice president of cardiovascular and immunology commercialization at Bristol Myers Squibb. ” This latest approval of Sotyktu confirms its important role in managing both skin and joint symptoms of psoriatic disease and is a key milestone as we continue to explore its development in diseases that have limited or no treatment options.” Dr. Philip J. Mease, director of rheumatology research at Providence Swedish Medical Center, also pointed to the drug's clinical impact. He said patients taking the treatment showed better quality-of-life scores during the trials. Safety Profile And Risks Doctors saw a safety profile similar to earlier psoriasis studies. Common side effects included respiratory infections, mouth ulcers, acne and higher muscle enzyme levels. The label also carries warnings on infection risk, viral reactivation and possible malignancies. Physicians must screen patients for tuberculosis before treatment starts. The FDA first approved the medicine in 2022 for moderate-to-severe plaque psoriasis. The new clearance expands its use to adults with psoriatic arthritis. Psoriatic arthritis affects joints, tendons and skin through chronic inflammation. Researchers estimate that up to 30% of people with psoriasis later develop the joint disease. BMY Price Action: Bristol-Myers shares fell 0.28% to $60.12 after hours on Friday. Image: Shutterstock/Bacsica