The FDA approved AbbVie’s Skyrizi to treat moderate to severe ulcerative colitis, adding another indication to the immunology drug’s arsenal.
Rick GonzalezAbbVie has said that UC patients make up one-third of the overall IBD market, and analysts expect the approval, which was announced Tuesday evening, to result in another multibillion-dollar opportunity for Skyrizi. Outgoing CEO Rick Gonzalez has repeatedly trumpeted Skyrizi and Rinvoq, another AbbVie immunology drug, as the future of the company since the first Humira biosimilars came to market in 2023.
Edward Loftus, the trial investigator of AbbVie’s pivotal studies in UC, told Endpoints News that the increasing number of newly-approved UC treatments and experimental drugs targeting TYK2 and TL1A has led to a “paradox” for physicians and patients, with so many options to choose from.
But he noted that Skyrizi’s safety profile makes it an appealing pick for treatment-naïve and already-treated patients compared to some drugs with boxed warnings.
“One of the things we’ve realized over the years is that most drugs that work for Crohn’s also work for ulcerative colitis, with few exceptions,” Loftus said. “I suspect that this is going to get a fair amount of uptake.”
Skyrizi, which is also approved for plaque psoriasis, psoriatic arthritis and Crohn’s disease, pulled in $7.8 billion in sales last year. Rinvoq’s sales totaled about $4.0 billion.
The approval is based on two Phase 3 studies, a 12-week induction study and a 52-week maintenance trial. Both studies hit their primary endpoints of improving clinical remission at their respective time periods over placebo.
Two doses of 180 mg and 360 mg were tested in the maintenance study after patients received 1,200 mg during the induction phase. After 52 weeks, Skyrizi induced remission rates of 40% and 38% in the respective cohorts, compared to 25% in the control group of patients who only received the drug during induction, good for a p-value of p<0.01.
The drug also hit secondary endpoints of endoscopic improvement and histological-endoscopic mucosal improvement rates.
Rob MichaelAs Gonzalez prepares to hand over the CEO reins to Rob Michael on July 1, AbbVie is expected to lean on the Skyrizi-Rinvoq combo to maintain its foothold in immunology. Within the last year, Gonzalez also took steps to beef up AbbVie’s portfolio, signing off on acquisitions for ImmunoGen and Cerevel Therapeutics.
The deals gave AbbVie access to an emerging ADC blockbuster in ImmunoGen’s Elahere and additional neuroscience programs, potentially quieting some of the criticism the company has faced about the lack of a “shiny object” in its internal pipeline.