Speculation Mounts for Potential FDA Panel Review of Health Risks from Xeljanz, Other JAK Inhibitors

Following recent concerns about heart rhythm problems and cancer linked to Xeljanz, federal drug regulators have been delaying approval decisions for similar medications from the same class, known as JAK inhibitors, raising questions about the future of the new generation of rheumatoid arthritis treatments.

Xeljanz (tofacitinib) was the first medication approved as a JAK inhibitor (Janus kinase inhibitor), which is authorized for treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. When it was first introduced by Pfizer in 2012, it joined a lucrative market which already included long-standing treatment options like Humira, Enbrel and other similar medications known as tumor necrosis factor (TNF) inhibitors.

Amid aggressive marketing over the past eight years, Pfizer grew Xeljanz into a blockbuster medication, generating annual sales in excess of $2 billion worldwide, with more than 200,000 prescriptions. However, data from a recently completed study has raised questions about serious side effects of Xeljanz, which are not disclosed on the drug’s warning label.

In February, the FDA issued safety communication about the potential Xeljanz cancer and heart risks, indicating data from a recently completed post-marketing study found users may be more likely to be diagnosed with cancer or experience major cardiovascular events.

Since then, the FDA has delayed a number of requests for approval involving JAK inhibitors, including both expanded use of Xeljanz and indications for newer medications from the same class, including Rinvoq and Olumiant. Some outside observers say this may be a sign the FDA is preparing to convene an advisory committee meeting, where a panel of outside experts may be asked to review the risk/benefit profile of the entire class.

The latest such move came on April 8, when Pfizer announced it had extended the review timeline for its new oral JAK inhibitor, abrocitinib, by three months. It also extended a review period for Xeljanz for three months, which Pfizer wants approved for an additional indication to treat ankylosing spondylitis (AS).

While the FDA has made no official announcement regarding either an advisory committee meeting or a risk/benefit review for Xeljanz and similar drugs as of this time, a number of industry publications suggest regulatory actions may soon be announced.

Xeljanz Heart and Cancer Lawsuits

The study behind the FDA 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.

Although the drug maker disclosed that lung cancer on Xeljanz was the most frequently reported malignancy identified in the study, no information has been provided about other types of cancer identified, or potential signs and symptoms for which former users should be monitored. In addition, it remains unclear how the Xeljanz cancer cases were distributed in time and across different doses of the medication, as well as how long users were monitored.

While awaiting access to the full data, rheumatologists and other experts have raised serious concerns about how the medication should be prescribed and question whether the FDA will be required to further restrict user of the medication, or even potentially recommend a Xeljanz recall. However, health experts caution that users should not stop taking the medication without first consulting with their own healthcare provider.

Former users are now contacting lawyers who are investigating Xeljanz lawsuits and class action claims, to seek additional information which has not been disclosed and compensation for treatments they may now require.