Eli Lilly and Company and Incyte Corp., Wilmington, announced that the U.S. Food and Drug Administration denied approval of an arthritis drug, citing the need for additional trials.(FDA) has issued a complete response letter for the New Drug Application (NDA) of the investigational medicine.
Incyte shares rose 1.86 percent in after-hours trading.
The drug baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis (RA).
The FDA indicated that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to answer safety concerns across. The companies disagree with the FDA’s conclusions. The timing of a resubmission will be based on further discussions with the FDA.
“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.”
Incyte is evaluating the impact of the complete response on its previously-issued milestone and R&D expense guidance for 2017.
The drug was approved last year by European Union regulators.
It is being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus, and a phase 3 trial for patients with psoriatic arthritis is expected to be initiated in 2017.
About 23 million people worldwide suffer from rheumatoid arthritis Approximately three times as many women as men have the disease.
