Bristol Myers Wins FDA Approval for Sotyktu for Psoriatic Arthritis

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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% …

Full story available on Benzinga.com

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