Eli Lilly and Incyte announced that the FDA has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). The NDA for baricitinib was submitted to the FDA in January 2016.
The FDA extended the action date to allow time to review additional data analyses recently submitted by Lilly in response to the FDA's Information Requests. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months.
"At Lilly, we are committed to improving the lives of people with life-long chronic diseases such as rheumatoid arthritis, a serious and disabling type of arthritis," said J. Anthony Ware, M.D., senior vice president, product development and interim president of Lilly Bio-Medicines. "We will continue to work closely with the FDA throughout the review process and we believe that baricitinib has the potential to be an effective treatment choice, especially for those patients for whom current therapies are not adequately addressing their disease."
This delay does not affect Lilly's previously-issued financial guidance for 2017.
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. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions.
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 was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in December 2016, recommending the approval of baricitinib—which if approved would be marketed as Olumiant. Baricitinib is also being studied in phase II trials for atopic dermatitis and systemic lupus erythematosus, and a phase III trial for patients with psoriatic arthritis is expected to be initiated in 2017.
Lilly and Incyte conducted four pivotal phase III clinical trials of baricitinib in patients with moderate to severe active rheumatoid arthritis to support regulatory submission in most countries. Two of the four studies included pre-specified comparisons to approved DMARDs: one to methotrexate (RA-BEGIN) and one to adalimumab (RA-BEAM). An additional phase 3 study was initiated to support clinical development in China. The clinical trial program includes a wide range of patients including those who are methotrexate-naïve, inadequate responders to methotrexate, inadequate responders to conventional synthetic disease modifying antirheumatic drugs, or inadequate responders to biologic DMARDs including TNF inhibitors. Patients completing any of the phase III studies can enroll in a long-term extension study.