New Drug Application Submitted for Once-Daily Baricitinib for RA Patients

JAK1/JAK2 inhibitor targets inflammatory and autoimmune diseases

A new drug application (NDA) has been submitted to the FDA for the approval of oral once-daily baricitinib (Eli Lilly/Incite Corporation) for the treatment of moderately to severely active rheumatoid arthritis (RA).

Baricitinib is the only once-daily oral selective Janus kinase-1 (JAK1) and JAK2 inhibitor currently in late-stage clinical studies for the treatment of inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3, and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of several inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK 3 in kinase assays.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib is currently in phase 3 clinical development for rheumatoid arthritis and in phase 2 development for psoriasis, diabetic nephropathy, atopic dermatitis, and systemic lupus erythematosus.

RA is an autoimmune disease characterized by inflammation and progressive destruction of joints. More than 23 million people worldwide have RA, and three times as many women as men develop the disease. Current RA treatment includes the use of nonsteroidal anti-inflammatory drugs (NSAIDs); oral disease-modifying antirheumatic drugs (DMARDs), such as methotrexate; and injectable biological response modifiers that target selected mediators implicated in the pathogenesis of RA.

Lilly and Incyte have completed four pivotal phase 3 clinical trials of baricitinib in patients with moderately to severely active rheumatoid arthritis to support regulatory submission in most countries.

Source: Eli Lilly and Company; January 19, 2016.