Sotyktu approved by U.S. FDA for treatment of psoriatic arthritis

The U.S. Food and Drug Administration approved Sotyktu for adults with active psoriatic arthritis, citing positive results from the POETYK PsA‑1 and PsA‑2 trials that showed improvements in ACR20 and Minimal Disease Activity measures.

Bristol Myers Squibb announced that the U.S. Food and Drug Administration has approved Sotyktu for the treatment of adults with active psoriatic arthritis. The approval was based on results from the pivotal POETYK PsA‑1 and POETYK PsA‑2 trials. Both trials evaluated the efficacy and safety of Sotyktu 6 mg once daily. Reported trial outcomes included significant improvements in disease activity measures. Key points: - The FDA approved Sotyktu for adults with active psoriatic arthritis. - The approval was supported by results from the POETYK PsA‑1 and POETYK PsA‑2 trials. - Trials evaluated Sotyktu at 6 mg once daily and reported significant improvements in American College of Rheumatology 20 (ACR20) and Minimal Disease Activity (MDA) responses. - The trials assessed both efficacy and safety of the medicine. - Steven Taylor, President and CEO of the Arthritis Foundation, is quoted as welcoming an additional oral treatment option for people living with psoriatic arthritis. Summary: The approval provides an additional oral treatment option for adults with active psoriatic arthritis based on positive trial findings. Undetermined at this time.