AbbVie's red-hot Rinvoq scores 4th FDA approval in 5 months

Fast & Furious, the pharma version, has a new superhero.

How else to describe the star turn of AbbVie’s Rinvoq? With an FDA approval Friday afternoon for ankylosing spondylitis (AS), the immunology drug has collected its fourth nod in five months.

Ironically, though, the blessing came on the same day that AbbVie reported a sales slowdown for the juggernaut. In the first quarter of this year, Rinvoq garnered $465 million, a 57% increase from the same quarter last year but short of analyst consensus of $490 million.

Friday’s green light comes after Rinvoq was sanctioned last December for psoriatic arthritis, this January for atopic dermatitis and in March for ulcerative colitis. It was initially approved in 2019 for rheumatoid arthritis.

The AS nod is for those who have had intolerance or inadequate response to one or more tumor necrosis factor (TNF) blockers, the class that AbbVie's megablockbuster drug Humira belongs to.

AbbVie built the case for approval on two trials that showed Rinvoq delivered improvement in symptoms of AS at Week 14. In one trial, evaluating patients that lacked success with one or two biologic disease-modifying anti-rheumatic drugs, 51% of Rinvoq patients achieved 40% improvement compared to 26% of the patients on placebo.

In the other trial, evaluating patients who didn’t improve with at least two nonsteroidal anti-inflammatory drugs, 44% of Rinvoq patients achieved the improvement target as opposed to 18% of those on placebo.   

AS is a chronic inflammatory musculoskeletal disease primarily affecting the spine. An estimated one out of every 200 adults in the U.S., or approximately 1.1 million people, is affected.

“There are limited treatment options for people living with ankylosing spondylitis, particularly when painful symptoms persist despite being on a TNF blocker treatment,” Cassie Shafer, CEO of the Spondylitis Association of America, said in the release.

AbbVie has pinned its hopes on Rinvoq and Skyrizi to pick up the slack when Humira loses its exclusivity in 2023. While Humira's sales reached $20.8 billion last year, AbbVie expects its two successor treatments to compensate for the expected drop in revenue. The company sees Rinvoq generating $8 billion in sales by 2025.

That appears within reach if Rinvoq can keep expanding its label and steer clear of the recent concerns over drugs in its JAK inhibitor class, which have been linked to safety issues.

Last year, a postmarketing study of Pfizer’s JAK drug Xeljanz turned up an increased risk of heart-related side effects and cancer. That prompted the FDA to update the black-boxed warning for all three oral JAK drugs (including Eli Lilly's Olumiant) and recommend the use of TNF blockers as an alternative.