Eli Lilly and Incyte were expecting an approval this weekend from the FDA for their blockbuster-in-waiting arthritis candidate baricitinib, but today announced that the agency wants more trial data, adding significant delays and costs.
“The [complete response] letter indicates that the FDA is unable to approve the application in its current form,” the partners for the oral JAK inhibitor say in an update.
“Specifically, 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 further characterize safety concerns across treatment arms.”
However, both Lilly and Incyte say they “disagree with the agency’s conclusions,” adding that the timing of a resubmission “will be based on further discussions with the FDA.”
Christi Shaw, recently made the president of Lilly Bio-Medicines after leaving Novartis, said: “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.
“We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”
The NDA has been sitting in the agency’s in-tray for 15 months, with 3 months added earlier this year to allow time for it to review “additional data analyses.”
The companies, which have been partnered since 2009 on the med, have undertaken a number of phase 3 tests, showing that it is non-inferior to methotrexate, the standard global starter drug for RA, based on the ACR20 response rate after 24 weeks of treatment.
Lilly and Incyte have also previously scored a successful head-to-head with Enbrel and Humira, and then followed up with a successful showdown with a placebo arm.
Lilly says it financial guidance will not be re-jigged in the wake of this, but Incyte “is evaluating the impact of the complete response on its previously-issued milestone and R&D expense guidance for 2017.” Any update will be made during a Q1 call.
This puts the FDA at odds with the European Medicines Agency (EMA), which recommended approval of baricitinib; the drug was approved in February under the name Olumiant.