Eli Lilly and Company and Wilmington-based Incyte announced promising results from two Phase 3 trials, which found Olumiant was superior to placebo in achieving scalp hair regrowth as early as 24 weeks in adults with severe hair loss from the sudden hair loss disease Alopecia areata.
The drug is similar to Incyte’s Jakafi blockbuster blood cancer drug Jakafi.
After first showing promise in treating arthritis, issues with side effects contributed to Incyte, at the time a much smaller company, to license the drug to Lilly, which handles research efforts. The drug has been approved for the treatment of some types of arthritis.
Improvements in scalp hair regrowth with Olumiant compared to placebo were achieved at 36 weeks for patients taking the drug in 2-mg and 4-mg oral doses. Phase 2 trials showed similar results.
In both studies, a more significant proportion of patients taking Olumant 4-mg than placebo also achieved complete regrowth or regrowth with minimal gaps in eyebrow and eyelash hair coverage at 36 weeks.
Alopecia areata is an autoimmune disease that can cause extreme and patchy hair loss on the scalp, face, and other body areas, along with emotional distress and related effects.
Olumant has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for treatment of the disease. Lilly plans to submit a supplemental New Drug Application (sNDA) to the FDA in the second half of 2021.
The average age of participants in the trials was 37.5 years old, and they had lived with A.A. for a mean of 12.2 years since first experiencing symptoms, with the onset for hair loss occurring at approximately age 25.
“These findings are promising for patients with severe alopecia areata, as they support the potential for Olumiant to help patients regrow hair on the scalp, eyebrows, and eyelashes,” said Brett King, M.D., associate professor of dermatology at Yale University School of Medicine and lead author of these analyses. “Because there are no approved systemic therapies for alopecia areata, there is a significant unmet need, and health care providers and patients eagerly await approved treatment options for this disease.”
Olumiant, a once-daily oral JAK inhibitor, was discovered by Incyte and licensed to Lilly.
It is approved in the U.S., and more than 75 countries as a treatment for adults with moderate to severe rheumatoid arthritis and is approved in more than 40 countries, including the European Union and Japan, for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Marketing authorization for treating hospitalized patients with Covid-19 has been granted in multiple countries, including Japan and Switzerland.
The U.S. FDA-approved labeling includes a Boxed Warning for serious infections, malignancy, and thrombosis. Baricitinib is also being investigated in alopecia areata (A.A.), juvenile idiopathic arthritis (JIA), and systematic lupus erythematosus (SLE).
In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement to develop and commercial baricitinib.