AbbVie's Rinvoq marches toward blockbuster ulcerative colitis nod even as JAK delays drag on

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AbbVie says its arthritis drug Rinvoq significantly topped placebo in a year-long phase 3 maintenance study. (AbbVie)

AbbVie has pegged much of its post-Humira hopes on its next-gen immunology med Rinvoq, which now appears one step closer toward what could be a $2 billion indication in ulcerative colitis. 

The Chicago-based pharma said on Tuesday that its rheumatoid arthritis drug “significantly” topped placebo at helping moderate to severe ulcerative colitis patients reach clinical remission after a year of treatment. 

The findings were part of a late-stage maintenance study evaluating two different doses of the company’s once-daily JAK inhibitor in patients who responded to the drug after eight weeks in two previous trials. In its latest findings, 42% percent of patients on a 15 mg dose, and 52% on 30 mg dose, reached the primary remission endpoint. That compared with just 12% of those on placebo. 

RELATED: AbbVie's arthritis hotshot Rinvoq grabs a win in ulcerative colitis

Further, Rinvoq hit all secondary endpoints following 52 weeks of treatment. Nearly half of the patients on the lower dose and 62% on the higher dose showed an endoscopic improvement, compared with 14% in the placebo group. Investigators found no new safety risks, AbbVie said. 

The findings are a positive sign for AbbVie, which is set to lose exclusivity for its megablockbuster immunology drug Humira in early 2023. The company has pinned its immunology hopes on Rinvoq and another new entrant Skyrizi.

By 2025, AbbVie expects annual sales of around $8 billion from Rinvoq, which is already approved for adults with moderate to severe rheumatoid arthritis who didn’t respond to previous treatment.

Still, class-wide safety concerns for JAK inhibitors have thrown up hurdles for Rinvoq in several new uses. On Friday, AbbVie said the FDA postponed its decision for Rinvoq’s applications in psoriatic arthritis and ankylosing spondylitis. The agency has also pushed back a verdict for Rinvoq in atopic dermatitis to July.

RELATED: AbbVie's big Rinvoq ambitions—and the larger JAK class—face even more uncertainty with latest FDA delays

The problem isn’t isolated to Rinvoq. The FDA has delayed a number of decisions in the drug class as it works through safety concerns shrouding Pfizer’s JAK inhibitor Xeljanz after a post-marketing study turned up risks for dangerous heart side effects and cancer.

AbbVie's delays, the second for its psoriatic arthritis bid, have cast doubt over the drugmaker’s ambitions to expand Rinvoq’s label, as Piper Sandler analyst Christopher Raymond observed in a Friday note. Still, it’s unlikely that Rinvoq “would be painted with the same brush as Xeljanz.”

If Rinvoq manages to cross the FDA’s finish line in ulcerative colitis, it could end up dominating the space over the likes of its competitors, such as Xeljanz and Gilead’s filgotinib, analysts have predicted. Bernstein analysts see Rinvoq raking in about $2 billion in sales given its strong performance in trials and positive safety readout, according to a note on Tuesday.