AbbVie's Rinvoq scores its 7th FDA nod, this one for Crohn's disease

In developing immunology treatment Rinvoq, AbbVie is employing the same game plan it used to make predecessor Humira a megablockbuster. And the company seems to be getting better at it.

Thursday, AbbVie scored its seventh FDA approval for Rinvoq in a span of less than four years, getting the JAK inhibitor across the finish line as a treatment for Crohn’s disease.

A look at Humira’s approval history shows that AbbVie has become more efficient in adding indications to its immunology blockbusters. After Humira was initially blessed in 2002, it took AbbVie 10 years to get the TNF blocker endorsed for its seventh disease type.

Coincidentally, Rinvoq’s new FDA approval came hours after the U.K.’s National Institute for Health and Care Excellence signed off on the drug for Crohn’s disease.

This is the second gastroenterology indication for Rinvoq after it won approval for ulcerative colitis in March of last year. Rinvoq’s first two green lights were for rheumatoid and psoriatic arthritis. Last year, AbbVie also tacked on nods for dermatitis, ankylosing spondylitis and axial spondyloarthritis.

The green lights have come despite concerns that JAK inhibitors have heart-related side effects, and restrictions have been placed on their use. Rinvoq has sidestepped the issues to some degree, generating sales of $2.5 billion last year, which was a 52% increase from 2021.

As Humira reaches its patent cliff, AbbVie is pushing Rinvoq hard. In advertising last year, the company spent $426 million—the second highest ad spend for drug last year, trailing only Regeneron and Sanofi’s Dupixent.

While there are a multitude of treatments for Crohn’s, Rinvoq is the first JAK inhibitor endorsed for the disease.

The go-ahead was based on two phase 3 induction studies that showed 34% and 46% of patients achieved endoscopic responses, respectively, compared with 3% and 13% of patients on placebo.

In a maintenance study, 28% and 41% of patients treated with 15-mg and 30-mg doses, respectively, achieved endoscopic responses at Week 52 compared to 7% of those on placebo.

“Based on the clinical trial results, treatment with Rinvoq shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation,” Edward Loftus Jr., M.D., professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota, and a U-EXCEL study investigator, said in a release.