Once-Daily Rheumatoid Arthritis Treatment Submitted for Review

Eli Lilly and Company and Incyte Corporation have submitted a new drug application to the FDA for the approval of oral once-daily baricitinib for the treatment of moderate to severe rheumatoid arthritis.

Eli Lilly and Company and Incyte Corporation have submitted a new drug application to the FDA for the approval of oral once-daily baricitinib for the treatment of moderate to severe rheumatoid arthritis.

Baricitinib is the only once-daily oral selective JAK1 and JAK2 inhibitor in late-stage clinical trials for inflammatory and autoimmune conditions, according to Lilly.

In the second phase 3 study of baricitinib, 2 doses of the treatment were evaluated in 684 patients with rheumatoid arthritis who previously did not respond adequately to at least 1 conventional disease-modifying antirheumatic drug.

The researchers found that those treated with baricitinib saw significant improvements compared with the patients who received placebo.

"Lilly's collaboration with Incyte has produced a rigorous phase 3 program and, if approved, the potential of a promising new treatment option for people with RA [rheumatoid arthritis]," said David Ricks, president of Lilly Bio-Medicines, in a press release.

Lilly would launch the global commercialization efforts for the drug if the application is approved.

“To date, baricitinib has demonstrated an acceptable safety profile and side effects have generally been straightforward to manage,” said Peter Taylor, Norman Collisson Chair of Musculoskeletal Sciences in the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences at the University of Oxford, in a press release. “These encouraging findings support further investigation of this new drug in rheumatoid arthritis.”