AbbVie's rising star Skyrizi nabs key ulcerative colitis FDA approval

2024-06-20

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AbbVie's rising star Skyrizi nabs key ulcerative colitis FDA approval

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来源: FiercePharma

With its latest approval, Skyrizi is now approved to treat both of the forms of inflammatory bowel disease.

AbbVie’s fast-growing Humira successor Skyrizi is already on a roll with skyrocketing sales. Now, the IL-23 inhibitor IL-23 inhibitor is poised to take on an even larger share of Humira’s fading market dominance with a key expansion into ulcerative colitis.

On Tuesday, the FDA granted Skyrizi approval to treat adult patents with moderately to severely active ulcerative colitis (UC). The approval adds some 1 million U.S. patients to the drug’s reach and makes Skyrizi the first IL-23 inhibitor IL-23 inhibitor cleared to treat both UC and Crohn’s, the two forms of inflammatory bowel disease (IBD).

Following a 12-week induction period, patients can dose themselves at home with an on-body injector device “designed with patients in mind," according to AbbVie's press release. The device adheres to the body and delivers the med in about five minutes.

Even in a crowded disease area, Skyrizi boasts an edge with prescribers. A Spherix Global Insights poll of 101 gastroenterologists found that doctors are already on board with the med as a UC treatment, with one-third reporting that Skyrizi is a significant advance over existing products.

Doctors favor AbbVie’s offering over Johnson & Johnson’s Tremfya and Abivax’s obefazimod, and most are highly familiar with the drug. One gastroenterologist said they prefer Skyrizi because it has “the best efficacy profile among the IL-23 agents.”

After its Crohn's approval in 2022, Skyrizi has been a formidable IBD rival to Johnson & Johnson’s blockbuster Stelara. The AbbVie drug has been taking a “significant share” of the J&J med’s sales, AbbVie executives said on an April earnings call.

Coupled with its other two approvals in psoriatic arthritis and plaque psoriasis, AbbVie is making strides in its plan to build up Skyrizi—as well as JAK inhibitor Rinvoq JAK inhibitor Rinvoq—to make up for falling Humira sales. Last year, Skyrizi’s sales reached $7.7 billion, a 50% leap over 2022.

The company has long been working on the double threat to buoy its immunology profile as once-king Humira falls to biosimilar competition following its loss of exclusivity in 2023. With the still-rising success of the two drugs, it’s looking like the plan might be coming to fruition even better than AbbVie once hoped.

Analysts at GlobalData expect Skyrizi sales to peak in 2030 at $19.7 billion, while Rinvoq should peak at $12.3 billion for a total haul of $32 billion. By the end of the decade, the duo is poised to contribute 42% of AbbVie’s total revenue.

“Given their 2030 drug expiries, these drugs are estimated to not only bolster sales for an extended period of time but […] are [also] poised for long-term sales growth, enabling the company to not only financially recover from Humira’s expiry but to also continue its position as a formidable player within the immunology therapy area,” GlobalData pharma analyst Jasper Morley said in the report.

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