FDA Rejects Lilly's Baricitinib


In a letter to the company, the FDA cited safety and dosage concerns as major factors in their decision.

FDA Rejects Baricitinib

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s New Drug Application (NDA) for baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis (RA).

In a letter to Lilly, the FDA said it rejected the application because additional clinical data was necessary to determine appropriate dosage levels and identify safety concerns across treatment arms — namely, an observed imbalance in thromboembolic events that occurred during the placebo-controlled period of the RA clinical program.

In a company statement, Lilly said it disagrees with the FDA’s rejection, and that it plans to resubmit the application within 18 months, contingent upon the outcome of upcoming discussions with the agency.

“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 US.”

The FDA has indicated that for an NDA to move forward, a new clinical trial must be conducted to further characterize the risk/benefit across doses. This request will not impact ongoing clinical trials for baricitinib, Lilly said in a statement.

Lilly’s NDA contained positive results from 4 phase 3 trials that met their primary endpoints. More than 3,100 patients were enrolled in the trials across a full spectrum of RA, from treatment naïve to highly-treatment refractory. Thromboembolic events — defined as deep venous thrombosis and pulmonary embolism – were reported in 5 patients receiving baricitinib during the controlled period of 2 of 7 complete phase 2 and 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,” the statement read.

Baricitinib 2-mg and 4-mg tablets have been approved in the European Union since February, however, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recently agreed to update the label with a precaution for patients who have risk factors for deep venous thrombosis and pulmonary embolism. A similar precaution has been placed on the drug’s label in Japan.

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