Incyte (NASDAQ:INCY) and licensee Eli Lilly (NYSE:LLY) announce results from a Phase 3 clinical trial, BREEZE-AD4,
evaluating Olumiant (baricitinib) in adults with moderate to severe
atopic dermatitis (AD) who were inadequate responders to, intolerant of
or contraindicated for cyclosporine.
The study met the primary endpoint of a
statistically significant proportion of patients achieving at least a
75% improvement in AD (EASI 75) from baseline at week 16 compared to
placebo at the highest dose (4 mg), but did not for the 1 mg and 2 mg
doses.
No new safety signals were observed.
Complete results will be submitted for presentation at future medical conferences and publication.
The FDA approved the JAK inhibitor in June 2018 for rheumatoid arthritis at a recommended dose of 2 mg once daily.
Lilly’s recently submitted its marketing
application for AD in Europe and plans to file applications in the U.S.
and Japan this year.
https://seekingalpha.com/news/3534611-lilly-and-incytes-olumiant-shows-mixed-results-in-late-stage-dermatitis-study
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