Additional Data Needed for Incyte’s Baricitinib

On April 14, 2017, Eli Lilly and Company and Incyte Corporation announced that FDA had denied approval of a new drug application (NDA) for baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis (RA). In a complete response letter, FDA stated that additional clinical data were needed to determine appropriate dosage and “to further characterize safety concerns across treatment arms.” The NDA was submitted in January 2016, and FDA granted a three-month extension for the review of additional data in January 2017.

The companies stated in a press release that they disagree with FDA’s decision. “We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA,” said Christi Shaw, president of Lilly Bio-Medicines, in the release. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the US.”

Baricitinib is a once-daily oral JAK inhibitor. According to Incyte, “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, including rheumatoid arthritis.” Lilly and Incyte entered into an exclusive worldwide license and collaboration agreement in December 2009 to develop and commercialize baricitinib and certain follow-on compounds. The drug was submitted for regulatory review in the United States, the European Union, and Japan in 2016. The EU approved the drug in February 2017. Globally, it is currently under Phase II trials for the treatment of atopic dermatitis and systemic lupus erythematosus. Additionally, a Phase III trial for the treatment of psoriatic arthritis is expected to be initiated in 2017.