Baricitinib for RA NDA Application Delayed at Least 18 Months

Officials with the FDA are requesting a new clinical study before Eli Lilly and Incyte Corporation can resubmit for a new drug application (NDA) for baricitinib, a once-daily oral medication for moderate-to-severe rheumatoid arthritis treatment.

"We disagree with the FDA's conclusions, and believe the existing comprehensive clinical data demonstrate there is a positive benefit/risk profile that supports baricitinib's approval as a new treatment option for people suffering from RA in the United States," Christi Shaw, president of Lilly Bio-Medicines said in a press release about the FDA's decision.

The companies will be further discussing the path forward with the agency and evaluating options for resubmission, including the potential for an additional clinical study, as requested by the FDA, according to the statement. The length of time to a resubmission for the NDA will depend on which option the companies pursue and further FDA discussions, but is anticipated to be a minimum of 18 months.

"We are disappointed that resubmission will not occur this year, but are committed to bringing baricitinib to people with RA and we will work with the FDA on the path forward," Shaw said.

The FDA has indicated that a new clinical study is necessary for a resubmission in order to further characterize the benefit/risk across doses, in light of the observed imbalance in thromboembolic events that occurred during the placebo-controlled period of the RA clinical program. This request for an additional clinical study does not impact the ongoing clinical trials for baricitinib.

The NDA for RA contained the results of 4 phase 3 clinical trials that met their primary endpoints and in which 3,100 patients were enrolled, across the full spectrum of RA patients from treatment-naïve to highly-treatment refractory. Thromboembolic events - diagnosed as deep venous thrombosis (DVT) and pulmonary embolism (PE) - were reported in five patients receiving baricitinib during the controlled period of two of seven completed phase 2 or phase 3 trials in RA. Although an imbalance was observed during the placebo controlled period of the RA clinical trials, the rate of these events in the overall baricitinib clinical program was consistent with that seen among the general population of treated RA patients, according to the company statement.

In the European Union, where baricitinib 2-mg and 4-mg tablets have been approved since February 2017, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recently agreed to update the label with a precaution for patients who have risk factors for DVT and PE. In Japan, where baricitinib was also recently approved, the label includes a similar precaution.

Reference

Lilly and Incyte Provide Update on Baricitinib [news release]. Indianopolis. Lilly website. Accessed July 25, 2017 at: https://investor.lilly.com/releaseDetail.cfm?ReleaseID=1034247