Eli Lilly and Co. and Incyte Corp. said Friday that the U.S. Food and Drug Administration (FDA) dismissed their request to approve baricitinib, the treatment of rheumatoid arthritis (RA), as a new drug.
The FDA indicated that it needs additional clinical data to determine its proper doses and to characterize safety concerns better. Eli Lilly said the Indianapolis-based company and its partner disagree with the FDA’s conclusions, adding that it might be able to speed the resubmission with more discussion.
“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. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”
Baricitinib is a once-daily oral JAK inhibitor currently in clinical tests for inflammatory and autoimmune diseases. Rheumatoid arthritis is a systemic autoimmune disease characterized by inflammation and progressive destruction of joints. More than 23 million people worldwide suffer from RA.
Current treatment of RA includes the use of non-steroidal, anti-inflammatory drugs, oral conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission.
Because of this, there is a critical need to provide additional treatments to improve overall patient care, the company said. Lilly and Incyte submitted a non-disclosure agreement (NDA) for baricitinib to the FDA in January 2016. In January 2017, the FDA announced a three-month extension to allow time to analyze the review of additional data.
Lilly and Incyte conducted four successful Phase 3 clinical trials of baricitinib in patients with moderate to severely active rheumatoid arthritis to support regulatory submission in most countries. An additional phase 3 study was initiated to support clinical development in China.
The clinical trial program includes a broad range of patients including those who are methotrexate-naïve, inadequate responders to methotrexate, poor responders to common synthetic disease-modifying antirheumatic drugs.