Eli Lilly & Co. and Incyte Corp. on Thursday said a pair of Phase 3 studies showed that once-daily four-milligram doses of their arthritis drug Olumiant was superior to placebo in achieving significant scalp hair regrowth as early as 24 weeks in adults with severe alopecia areata.
The companies earlier this year had reported that the studies showed significant improvements in scalp hair regrowth compared with placebo at 36 weeks for patients taking 2- and 4-milligram doses.
Eli Lilly said it plans to file for U.S. Food and Drug Administration approval for Olumiant in alopecia areata by the end of the year. There are currently no FDA-approved treatments for the autoimmune disorder, which can cause unpredictable hair loss on the scalp, face and other areas of the body.
Olumiant is approved in dozens of countries around the world for adults with moderate to severe rheumatoid arthritis and for adults with moderate to severe atopic dermatitis who are candidates for systemic therapy. The drug is also approved for the treatment of hospitalized patients with Covid-19 in several countries, including Japan and Switzerland.
Indianapolis-based Eli Lilly signed an exclusive world-wide license and collaboration agreement with Incyte, a Wilmington, Del., biopharmaceutical company, in late 2009 to develop and commercialize Olumiant and other compounds for inflammatory and autoimmune diseases.
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