Skyrizi from AbbVie gains crucial FDA approval for ulcerative colitis

AbbVie's fast-growing drug Skyrizi has recently received approval from the FDA to treat adult patients with moderately to severely active ulcerative colitis (UC). This expansion into ulcerative colitis, one of the two main forms of inflammatory bowel disease (IBD), significantly broadens Skyrizi's reach. Already approved for Crohn's disease, Skyrizi becomes the first IL-23 inhibitor to be cleared for both UC and Crohn's. This could extend the drug’s potential market in the U.S. by about 1 million patients.

Skyrizi's new approval allows patients, following a 12-week induction period, to administer the medication at home using an on-body injector device. According to AbbVie, this device is user-friendly and delivers the medication in approximately five minutes. This convenience, combined with the drug’s efficacy, has made it a favored option among gastroenterologists.

In a poll conducted by Spherix Global Insights involving 101 gastroenterologists, many doctors expressed their preference for Skyrizi over other treatments such as Johnson & Johnson’s Tremfya and Abivax’s obefazimod. One gastroenterologist highlighted Skyrizi's superior efficacy profile among IL-23 inhibitors as a key reason for this preference.

Since its approval for Crohn's disease in 2022, Skyrizi has posed significant competition to Johnson & Johnson’s Stelara. AbbVie executives noted during an April earnings call that Skyrizi has captured a substantial share of Stelara’s market. Skyrizi is also approved for treating psoriatic arthritis and plaque psoriasis, making it a versatile player in AbbVie's portfolio.

AbbVie’s strategic focus on Skyrizi and another drug, the JAK inhibitor Rinvoq, is part of its broader plan to compensate for declining sales of Humira, which has lost market exclusivity and faces competition from biosimilars. Last year, Skyrizi generated $7.7 billion in sales, marking a 50% increase compared to 2022.

The company’s strategy appears to be successful. Analysts at GlobalData project that Skyrizi's sales will peak at $19.7 billion by 2030, while Rinvoq is expected to reach $12.3 billion, contributing a combined total of $32 billion. By the end of the decade, Skyrizi and Rinvoq are anticipated to account for 42% of AbbVie's total revenue.

The expiration of these drugs in 2030 will still allow AbbVie to enjoy a prolonged period of revenue growth. According to GlobalData pharma analyst Jasper Morley, these drugs will not only help AbbVie financially recover from Humira’s expiry but also ensure the company’s strong position in the immunology therapy sector.

In conclusion, Skyrizi's expanded approval to include ulcerative colitis represents a significant step forward for AbbVie. The drug’s home-use convenience and strong efficacy profile make it a preferred option among healthcare providers. Coupled with Rinvoq, Skyrizi is poised to play a crucial role in AbbVie's strategy to sustain its leadership in the immunology market as it navigates the challenges posed by the decline of Humira.