Are there any lawsuits against Xeljanz?

Pfizer has had a tough few years marketing its rheumatoid arthritis drug Xeljanz, as regulatory agencies have slapped warnings on the JAK inhibitor about potential cardiovascular unwanted effects and cancer risk.

A brand new study promises to help make the marketing challenge even greater.

The research, which was a post-marketing trial required by the FDA, compared Xeljanz to a TNF inhibitor in more than 4,300 patients over age 50 who had RA and at least one cardiovascular risk factor. There were 98 cases of cardiovascular events on the list of Xeljanz patients, versus just 37 in the TNF inhibitor group. And 122 patients taking Xeljanz developed cancers, weighed against 42 on TNF inhibitors.

Xeljanz thus missed the trial's primary endpoints, of to exhibit non-inferiority to TNF inhibitors in both cardiovascular and cancer risk. Two doses were tested, and both missed the mark, Pfizer said.

The effect wasn't entirely surprising, given the pileup of warnings on JAK inhibitors in recent years. In 2019, the FDA warned of an elevated risk of blood clots and possibly death for patients taking 10 mg of Xeljanz twice daily. Pfizer had already flagged the safety issue and switched patients in a postmarketing study to the 5 mg dose, but the FDA was concerned enough to slap the dreaded “black box” warning on the drug.

The European Medicines Agency followed a few months later with a warning suggesting Xeljanz at any dose ought to be used in combination with caution in patients who face a top threat of blood clots.

And these days, Pfizer isn't just facing competition from TNF inhibitors like AbbVie's Humira. It also includes a tough rival in AbbVie's JAK inhibitor Rinvoq, already approved to treat RA.

AbbVie is also pursuing an ulcerative colitis approval for Rinvoq. In December, the Illinois-based drugmaker released results from a phase 2b/3 study showing Rinvoq helped 26% of patients achieve remission at eight weeks, versus just 5% of patients taking a placebo.

For more details kindly visit post-marketing Xeljanz safety study.