Rinvoq Approved As Atopic Dermatitis Treatment Despite Heart, Cancer Risks

The move comes after the FDA held up Rinvoq approvals for months due to concerns it carried similar cancer and heart risks as Xeljanz.

Federal drug regulators have granted the makers of Rinvoq another approved use of the arthritis drug, despite recent concerns that side effects of Rinvoq and other similar medications may increase the risk of blood clots, heart problems and cancer.

On January 14, AbbVie issued a press release announcing that the FDA had approved Rinvoq for the treatment of refractory, moderate to severe atopic dermatitis among patients ages 12 and older. The approval includes doses of both 15mg and 30mg strength.

The new approved indication comes about a month after the agency added new label warnings about side effects of Xeljanz, Rinvoq and Olumiant, indicating that users of the entire class of medications, known as Janus kinase (JAK) inhibitors, may be more likely to experience a heart attack, stroke, cancer, blood clots and death.

Xeljanz is the most widely used drug of the class, and was the first introduced on the U.S. market. However, the entire class has been plagued by safety concerns since a recent clinical trial identified a potential link between Xeljanz and cancer, heart attacks and other serious problems that were not initially disclosed on the drug labels.

Since all JAK inhibitors work in a similar way, those concerns quickly spread to Rinvoq, and the FDA announced in September that new warning labels were being required for all drugs in the class, which are now considered a second-line arthritis treatment behind TNF blockers, such as Enbrel, Humira and Remicade.

AbbVie indicates the FDA approved the expanded use of Rinvoq based on clinical trial data, which involved about 2,500 patients over three studies. However, the FDA previously delayed Rinvoq approvals while it was evaluating the potential side effects of Xeljanz and whether the problems applied to the entire class of drugs.

The FDA first raised concerns about Xeljanz cancer and cardiovascular side effects in a drug safety communication in February 2021, after reviewing preliminary data from a postmarketing study. As a result, in June, AbbVie announced expanded approval for Rinvoq was being held up due to similar problems. Before that, in April, Pfizer announced the review for its new oral JAK inhibitor, abrocitinib, had been extended by three months due to the same concerns.

In July, media reports indicated Lilly and Incyte also announced the FDA delayed approval of Olumiant; another new-generation rheumatoid arthritis drug seeking expanded approval as an eczema treatment. It has already been approved to treat the skin condition in 40 countries.

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 and class action claims, to seek additional information which has not been disclosed and compensation for treatments they may now require.