The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued United States-based Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) with a positive opinion for baricitinib (marketed as OLUMIANT), intended for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy, it was reported on Friday.
This opinion represents the first step toward European regulatory approval for the product for patients with AD. If the product is approved, it is to become the first JAK inhibitor indicated to help treat patients with AD. The European Commission is likely to take a final decision in the next one-to-two months.
The positive opinion was based on the company's Phase three BREEZE-AD clinical development program for the product, assessing the medicine's potential to treat AD including BREEZE-AD1 and BREEZE-AD2, monotherapy studies investigating the efficacy and safety of baricitinib in moderate to severe AD patients; BREEZE-AD4, a study assessing the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD who have failed or who are intolerant to, or have contraindications to cyclosporine; and BREEZE-AD7, a study assessing the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD.
OLUMIANT is already approved in more than 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).
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