Healthcare company Eli Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY) on Monday jointly announced the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis (RA), a systemic autoimmune disease characterised by inflammation and progressive destruction of joints.

The company said the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate.

According to the company, baricitinib is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. The JAK inhibitors may be useful for treating inflammatory conditions, including rheumatoid arthritis.

However, the US FDA 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. Baricitinib 2-mg and 4-mg doses are approved in more than 40 countries, including the member states of the EU and Japan.

In conjunction, the US FDA Advisory Committee's recommendation was based on baricitinib's global development programme, which included four completed Phase 3 studies. The Phase 3 studies evaluated baricitinib's treatment impact related to RA signs and symptoms, physical function, joint damage progression and other outcomes in 3,492 patients, concluded the company.