Janssen Pharmaceutical’s Phase 3 DISCOVER 1 and 2 studies evaluating the safety and efficacy of guselkumab in adults with active moderate to severe psoriatic arthritis met their primary endpoints of American College of Rheumatology 20% improvement.
Safety profiles observed for guselkumab in the DISCOVER program were consistent with previous studies of guselkumab and Tremfya current prescribing information.
Johnson & Johnson’s (NYSE:JNJ) Janssen unit says the data from the studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval for guselkumab as treatment for psoriatic arthritis, which are anticipated for later this year.
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