FDA Approves New Drugs for Pain

CHS-0214 is another investigational ETN biosimilar. The treatment met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study evaluating its efficacy and safety in patients with moderate to severe chronic plaque psoriasis.¹⁰ The efficacy endpoints were based on a 12-week assessment of Psoriasis Activity Severity Index (PASI) scores. The primary endpoints were the mean percent change in PASI from baseline and the proportion of patients achieving 75% improvement in PASI from baseline. These results met the pre-specified limits for demonstrating an equivalence to ETN. No clinically meaningful differences were noted in the safety profiles of the two products evaluated.

Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

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