Eli Lilly (NYSE:LLY) and Incyte (NASDAQ:INCY) are marching forward in their quest to gain regulatory approval for Olumiant as a treatment for atopic dermatitis (AD), commonly referred to as eczema. https://www.globenewswire.com/news-release/2020/02/11/1983486/0/en/Lilly and-Incyte-Announce-Positive-Top-Line-Results-from-the-North-American-Phase-3-Study-BREEZE-AD5-of-Oral-Selective-JAK-Inhibitor-Baricitinib-in-Patients-with-Moderate-to-Severe.html
Last month, the companies showed that the drug in combination with topical corticosteroids helped patients reduce their eczema symptoms. And now the healthcare companies have demonstrated that the monotherapy is able to help eczema patients as well.
In the Breeze-AD5 study, 29.5% of patients taking the higher dose of Olumiant had at least a 75% or greater change from baseline in their Eczema Area and Severity Index score (EASI75), compared with 8.2% of patients taking placebo. The lower dose of Olumiant helped 12.9% of patients reach the goal, but the result wasn't statistically better than a placebo.
The higher dose also helped 24% of patients reach clear or almost clear skin, with at least a 2-point improvement on the validated Investigator's Global Assessment for AD, compared with 5.4% of patients taking a placebo. The lower dose helped 12.9% of patients reach the goal, which was statistically better than the placebo result.
A third endpoint that measured itch sensitivity also showed that both doses worked better than a placebo, with the higher dose producing a better result than the lower dose, as expected.
Olumiant is already approved to treat rheumatoid arthritis, but an expansion into eczema would expand the potential market for the drug substantially. Eli Lilly has applied for expanded approval to treat eczema in the EU. With the final clinical trial in the Breeze clinical trial program complete, the company plans to submit marketing applications to expand the approval in the U.S. and Japan this year.