(RTTNews) - Eli Lilly and Co. (LLY) and Incyte Corp. (INCY) said Friday that that the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
The companies noted that the opinion marks the first step toward European regulatory approval for baricitinib (marketed as Olumiant) for patients with AD. If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD.
The CHMP opinion is now referred for action to the European Commission, which grants approval in the European Union. The companies expect a final decision from the European Commission in the next one to two months.
The positive CHMP opinion for baricitinib was based on Lilly's Phase 3 BREEZE-AD clinical development program for baricitinib evaluating the medicine's potential to treat AD.
This includes BREEZE-AD1 and BREEZE-AD2, monotherapy studies investigating the efficacy and safety of baricitinib in moderate to severe AD patients; and BREEZE-AD4, a study to evaluate 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.
It also includes BREEZE-AD7, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD.
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