The pharma version of Fast and Furious has a new superhero. How else to characterise AbbVie’s Rinvoq’s breakthrough effectiveness? The immunology medicine received its fourth FDA approval in five months on April 29th for ankylosing spondylitis. The blessing, however, came on the very day AbbVie revealed a decrease in the juggernaut’s sales. Rinvoq made $465 million in the first quarter of this year, up 57 percent from the very same quarter last year but falling short of analyst expectations of $490 million.
Rinvoq was previously approved for psoriatic arthritis in December of last year, atopic dermatitis in January of this year, and ulcerative colitis in March of this year. It was first licenced in 2019 for the treatment of rheumatoid arthritis. The AS approval is for patients who have experienced intolerance or a poor response to one or more tumour necrosis factor (TNF) inhibitors, which includes AbbVie’s megablockbuster medicine Humira.
AbbVie based its argument for approval on two clinical trials that demonstrated Rinvoq improved AS symptoms at week 14. In one study of patients who had failed to respond to one or two biologic disease-modifying anti-rheumatic medications, 51 percent of Rinvoq patients improved by 40 percent, compared to 26 percent of placebo patients. In a separate experiment involving patients who had not improved after taking at least two nonsteroidal anti-inflammatory medicines, 44 percent of Rinvoq patients met the improvement goal, compared to only 18 percent of placebo patients.
AS is a chronic musculoskeletal inflammatory condition that primarily affects the spine. One in every 200 American adults, or around 1.1 million people, are thought to be impacted. In the announcement, Cassie Shafer, CEO of the Spondylitis Association of America, said that there are limited therapy alternatives for people diagnosed with ankylosing spondylitis, especially when painful symptoms linger despite being on a TNF-blocker treatment.
When Humira’s monopoly expires in 2023, AbbVie is banking on Rinvoq and Skyrizi to fill the void. Despite Humira’s $20.8 billion in sales last year, AbbVie anticipates its two replacement therapies will make up for the predicted revenue decline. Rinvoq is expected to generate $8 billion in revenue by 2025, according to the business.
Rinvoq appears to be on track to meet that goal if it can continue to broaden its label and avoid the recent safety concerns surrounding medications in the JAK inhibitor family. In a postmarketing study last year, Pfizer’s JAK medication Xeljanz was found to have an elevated risk of heart-related adverse events and cancer. The FDA updated the black-box warnings for all three oral JAK inhibitors, Eli Lilly’s Olumiant included, and suggested that TNF blockers be used instead.