Despite classwide safety worries in the U.S., AbbVie is making strides in its quest to build immunology up-and-comer Rinvoq.
AbbVie sent off applications to U.S. and European regulators in hopes of a non-radiographic axial spondyloarthritis (nr-axSpA) nod for the megablockbuster-in-waiting.
AbbVie is counting on the JAK inhibitor, plus psoriasis med Skyrizi, to ease the pain once Humira biosimilars hit the scene next year. The drugmaker has forecasted $1 billion sales for Rinvoq (upadacitinib) by 2025 across the entire spondyloarthritis field. Aside from nr-axSpA, the FDA is reviewing a Rinvoq application in ankylosing spondylitis, and the drug is already approved in that indication in Europe.
The latest nr-axSpA applications specifically cover patients with objective signs of inflammation who haven't responded well to nonsteroidal anti-inflammatory meds, AbbVie said Monday.
In the U.S., Rinvoq is approved in rheumatoid arthritis and psoriatic arthritis. Across the pond in the European Union, the JAK inhibitor boasts green lights in both those diseases, plus atopic dermatitis and ankylosing spondyllitis.
"Axial spondyloarthritis is a chronic inflammatory disease affecting the spine and can cause patients, who tend to be younger adults living active lives, to suffer from debilitating pain and significantly decrease their quality of life," Thomas Hudson, M.D., senior vice president of research and development and chief scientific officer at AbbVie, said in a statement.
Ankylosing spondylitis, for its part, covers cases where inflammatory changes to the joints or the spine can be seen on an X-ray.
Alongside its non-radiographic approval bid, AbbVie is seeking a European label extension for Rinvoq to add adult patients “with active ankylosing spondylitis who had an inadequate response to biologic disease-modifying anti-rheumatic drugs.”
In support of the move, AbbVie cited data from its phase 3 Select-Axis 2 trial, plus two-year results from its phase 2/3 Select-Axis 1 study. The FDA has received those data as well, as part of its ongoing review of Rinvoq in ankylosing spondylitis, AbbVie said.
As for the potential non-radiographic disease nod, AbbVie is leveraging data from Select-Axis 2, where Rinvoq hit its primary endpoints, as well as “most ranked secondary endpoints,” AbbVie said in a release. Once-daily treatment with Rinvoq 15mg curbed signs and symptoms of the disorder, including back pain and inflammation, AbbVie said. The drug also charted improvements in physical function and disease activity at the 14-week mark versus placebo, the drugmaker added.
Safety across patients in these trials was “generally consistent” with Rinvoq’s established profile, and no new safety risks cropped up. That’s good news, given the recent safety concerns plaguing the JAK inhibitor class at large.
In September, the FDA added a classwide boxed warning to Rinvoq’s label to include information about increased risks of serious heart-related events, cancer, blood clots and death. The regulator also downgraded Rinvoq’s use in rheumatoid arthritis behind TNF blockers in its approved indication. Similar fates befell Pfizer’s Xeljanz and Eli Lilly’s Olumiant.
AbbVie is counting on its next-gen immunology drugs Rinvoq and Skyrizi to hold the line once its blockbuster Humira falls off a 2023 patent cliff.
Both meds made impressive progress in 2021. In the third quarter, Rinvoq snared $453 million in global sales, up from $378 million in the second. Skyrizi, for its part, ginned up $796 million in Q3, up from $674 million the quarter before that.