Makers of Oluminant Withdraw Lupus Treatment Approval Request in Face of JAK-Inhibitor Health Risks

The manufacturer also expects the FDA to reject approval for the drug for the treatment of atopic dermatitis due to FDA safety cocerns.

Amid growing concerns over the side effects of Xeljanz and other JAK-inhibitor drugs in the same class of medications, the makes of Olumiant have decided not to pursue approval for use of the rheumatoid arthritis JAK-inhibitor as a potential lupus treatment.

In a January 28 press release, Eli Lilly and Company and Incyte announced they will not develop Olumiant for the treatment of lupus. In addition, the manufacturers and the U.S. Food and Drug Administration are at an impasse on approving the drug for treatment of moderate-to-severe atopic dermatitis.

Xeljanz (tofacitinib) and Olumiant (baricitinib) are both part of the same new class of medications, known as JAK inhibitors, which are prescribed to tamp down overactive immune system and ease joint pain associated with rheumatoid arthritis. The class also includes Rinvoq (upadacitinib), and the medications have quickly grown to become blockbuster drugs and widely recognized brands, amid direct-to-consumer advertising.

In September, the U.S. Food and Drug Administration (FDA) announced a new “black box” warning for Xeljanz, Olumiant and Rinvoq, requiring all manufacturers of JAK inhibitors to include information about an increased risk of heart attacks, strokes, cancer, blood clots and death, following a review of data from a large randomized clinical trial involving Xeljanz, which was the first member of this class to hit the market.

“Based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE I and II), Lilly has decided to discontinue the Phase 3 development program for Olumiant in lupus,” the press release states. “Key secondary endpoints were not met in either study.”

While the company says safety findings from previously published Olumiant data did not impact its decision not to seek approval, the company notes in its atopic dermatitis regulatory update that there is a disapproval with the FDA over Olumiant’s safety profile, saying the company “does not have alignment” with the FDA.

The press release states there is a possibility it will receive a Complete Response Letter for Olumiant’s atopic dermatitis drug approval, which usually indicates the agency has rejected a request to approve a drug for a new use.

The drug is already approved as an atopic dermatitis drug in the European Union and Japan.

The study behind the FDA’s Xeljanz concerns was initially launched in January 2012, and given the long latency period for many cancers, many users now face concerns they require on-going medical monitoring to detect and diagnose cases in the future.

Former users are now contacting lawyers who are investigating Xeljanz lawsuits over injuries that may been prevented if earlier warnings and information had been provided about the risk of heart attacks, cancer and blood clots.