Pfizer, Inc. is shelling out big bucks to advertise Xeljanz, its blockbuster rheumatoid arthritis medication.
Last month alone, the drug maker spent $26.2 million on Xeljanz TV commercials. AbbVie, Inc. was the only pharmaceutical company to spend more a single drug, as its Humira advertising expenditures topped $31 million in March.
Humira also took the top spot for all of 2018, with AbbVie spending $587 million to advertise its Xeljanz rival.
Pfizer invested $257 million to air Xeljanz TV commercials last year, earning it third place. The company’s Lyrica ($272 million) ranked second for advertising spends, while its smoking-cessation drug Chantix ($212 million) took fourth place.
Pfizer’s Xeljanz TV commercial spending actually fell about 6% in 2018. Yet the company made $178 billion from Xeljanz sales, enough to maintain its status as one of Pfizer’s top-selling brands.
The U.S. Food & Drug Administration (FDA) initially approved Xeljanz (5 mg twice daily) in 2012. It was the first-ever oral Janus kinase inhibitor indicated to treat adults with moderate-to-severe rheumatoid arthritis.
The FDA would go on to approve Xeljanz XR, an 11 mg, once daily, extended release tablet, in 2016. The agency cleared both Xeljanz versions for psoriatic arthritis the following year, and cleared a 10 mg twice-daily Xeljanz regimen to treat ulcerative colitis in 2018.
When the FDA first approved Xeljanz in 2012, it ordered Pfizer to conduct a post-market trial comparing the rate of heart-related events, cancer, and opportunistic infections among rheumatoid arthritis patients treated with either: a 5 mg twice-daily dose of Xeljanz; the 10 mg twice-daily Xeljanz regimen; or older, injectable drugs called tumor necrosis factor (TNF) inhibitors. The FDA stipulated that all participants be over 50 and have at least one cardiovascular risk factor.
Pfizer launched the 4,400-subject study two years later. According to preliminary findings, patients in the higher dose Xeljanz group were 5-times more likely to have a pulmonary embolism (a blood clot in the lungs) compared to those treated with TNF inhibitors. They were 3-times more likely to experience the potentially deadly blood clots compared to patients on the lower Xeljanz dose.
The higher-dose Xeljanz group also had more deaths from all causes compared to either of the other two groups.
Because of the preliminary findings, Pfizer began transitioning all patients in the study’s 10mg Xeljanz arm to the lower dose group in February. The trial will continue and is expected to be completed by the end of this year.
Nearly a week later, the FDA issued a Drug Safety Communication reminding doctors that the 10 mg twice-daily dose of Xeljanz is only approved to treat ulcerative colitis.
The FDA also warned patients not to stop taking Xeljanz without talking to their doctor, as this could cause their condition to worsen. They should also seek immediate medical help if they experience signs of a Xeljanz pulmonary embolism, including:
The FDA is working with Pfizer to evaluate other currently available Xeljanz safety data and will issue an update once its review is complete.