FDA’s Arthritis Advisory Committee recommends approval of Eli Lilly’s, Incyte Corporation’s 2-mg dose of baricitinib

Eli Lilly and Incyte Corporation scored a recommended approval of the 2-mg dose of a once-daily oral medication baricitinib from the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee, for the treatment of rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate.

According to the press release form Eli Lilly, the Advisory Committee did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.

Christi Shaw, president of Lilly Bio-Medicines said that disappointment with the Advisory Committee’s assessment of the data for the 4-mg dose, still leaves confidence in the positive benefit-risk profile of both the 2-mg and the 4-mg doses. “We look forward to continuing our work with the FDA on our New Drug Application (NDA) and are hopeful that baricitinib will receive approval in the coming months,” Shaw said.

Baricitinib 2-mg and 4-mg doses are approved in more than 40 countries, including the member states of the European Union and Japan.

Peter Taylor, an expert who attended the Advisory Committee Meeting, said: “Despite advances in the management of RA over the last 20 years, which include early treatment, optimized use of traditional therapies for rheumatic disease and the advent of newer medications such as biologics, many patients are still struggling to meet treatment targets, and live with debilitating pain, fatigue and other symptoms of RA. Baricitinib could be a promising option for RA patients in the U.S. who are not achieving adequate disease control with currently available treatments.”