AbbVie's Skyrizi, playing catch-up to immunology compatriot Rinvoq, snags 3rd nod

AbbVie’s immunology stalwart Skyrizi continued its ascent Friday, as the drug clinched a third indication and its second FDA approval of the year.

Thanks to a thumbs up from the U.S.’ drug regulator, Skyrizi, also known as risankizumab-rzaa, now wears the crown as the first specific interleukin-23 (IL-23) inhibitor cleared to treat adults with moderate to severely active Crohn’s disease (CD).

FDA handed down its approval after Skyrizi turned out “significant improvements” in endoscopic response and clinical remission versus placebo, both as an induction and maintenance therapy, across three trials, AbbVie said in a release.

Just few months back, Skyrizi locked up its second-ever nod, which was for adults with active psoriatic arthritis. That news positioned the drug to treat an inflammatory disease that affects roughly 30% of psoriasis patients, the Illinois-based drugmaker noted at the time. The IL-23 med is also approved to treat plaque psoriasis.

Crohn’s disease patients on Skyrizi will start by receiving a 600 mg infusion for at least one hour at weeks 0, 4 and 8 of treatment. After that, beginning at week 12, patients will switch over to a 360 mg, self-administered subcutaneous injection with an on-body injector, AbbVie said. Patients will dose themselves every 8 weeks thereafter.

The FDA is also weighing a 180 mg self-administered dosing option, AbbVie pointed out.

The regulator based its approval decision on two induction studies—Advance and Motivate—plus the maintenance trial Fortify. In the induction studies, a “significantly greater proportion” of patients on Skyrizi hit endoscopic response and clinical remission versus placebo. What’s more, as early as week 4 of the study, clinical response and remission were met in a “significantly greater proportion of patients receiving Skyrizi.”

In the 52-week maintenance study Fortify, meanwhile, a significant number of Skyrizi patients hit the trial’s co-primary endpoints of endoscopic response and clinical remission compared to the control cohort after one year.

AbbVie’s Crohn’s green light comes amid something of an approval tear for Skyrizi’s immunology compatriot Rinvoq, which has racked up approvals in ankylosing spondylitis, ulcerative colitis, atopic dermatitis and psoriatic arthritis in short order.

Skyrizi and Rinvoq are cornerstones in AbbVie’s post-Humira battle plan. Together, the drugmaker expects the meds to reap a combined $15 billion in sales in 2025.

Over the first three months of 2022, both Skyrizi and Rinvoq grew sales, though it was Skyrizi that stole the show. The IL-23 inhibitor recently delivered first-quarter sales of $940 million, jumping 65.6% and beating consensus estimates of $909 million.

Over that same stretch, JAK inhibitor Rinvoq posted revenues of $465 million. That marked a 57% increase year-over-year, though the med’s sales fell below analysts’ consensus estimates of $490 million.