Press release
CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis
Positive Opinion is the First Regulatory Action for Baricitinib as an Atopic Dermatitis Medicine INDIANAPOLIS, Sept. 18, 2020 /PRNewswire/ -- Eli Lilly and
About this update from Incyte Corporation
[{"type":"text","content":"Positive Opinion is the First Regulatory Action for Baricitinib as an Atopic Dermatitis Medicine\n\n\nINDIANAPOLIS, Sept. 18, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (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. \nThis 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. A final decision is expected from the European Commission in the next one-two months. \n\"Due to the limited treatment options currently available for adult patients with AD, we're excited to further explore baricitinib's potential benefit for patients,\" said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. \"At Lilly, we aspire to elevate treatment standards for patients with dermatologic conditions. Today's CHMP opinion brings us closer to providing a new medicine for adults living with AD in Europe.\" \nThe positive opinion was based on Lilly's Phase 3 BREEZE-AD clinical development program for baricitinib evaluating 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 evaluating 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 evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD.\n\"Patients living with AD face difficulties on a daily basis, and this CHMP opinion marks an important milestone in providing adult AD patients with a new potential treatment option,\" said Prof. Thomas Bieber, M.D., Ph.D., M.D.R.A., Professor of Dermatology and Allergy, University Hos...