AbbVie Expands Portfolio with SKYRIZI Approval for Ulcerative Colitis | DelveInsight

AbbVie's evolving drug portfolio, notably featuring the Humira successor SKYRIZI, is making significant strides in the treatment landscape for ulcerative colitis (UC). With its introduction into the UC market, SKYRIZI, an IL-23 inhibitor, is set to capture a substantial portion of Humira's market share as the latter's dominance wanes.

Ulcerative colitis is a chronic inflammatory bowel disease of unknown etiology, impacting approximately 1.5 million individuals in the United States. The disease specifically affects the colonic mucosa, presenting symptoms such as diarrhea, abdominal pain, discomfort, and rectal bleeding. The severity of UC varies, with some patients experiencing limited involvement of the rectum or left side of the colon, while others endure widespread colonic inflammation.

According to DelveInsight, the prevalence of diagnosed UC cases in key markets (7MM) was around 3 million in 2023, with projections indicating an increase by 2034. Of these cases, an estimated 60% are classified as moderate to severe. The current UC treatments span six primary categories: conventional therapies, Anti-TNFs, Anti-integrin agents, IL-12/IL-23 dual inhibitors, S1P-receptor modulators, and JAK inhibitors. Emerging therapeutic approaches are exploring new mechanisms such as LANCL2 protein stimulators, miR-124 enhancers, and TNF-like ligand 1A inhibitors, which promise to expand and enhance the treatment landscape for UC.

Despite advancements, the safety and efficacy of UC treatments remain a significant concern, affecting patients' quality of life. Many patients require multiple lines of therapy to achieve disease control, underscoring the need for alternative treatment options. In response, several major pharmaceutical companies are collaborating to develop innovative solutions.

The market already has several FDA-approved drugs for UC treatment, including SIMPONI, ENTYVIO, OMVOH, VELSIPITY, and SKYRIZI. SIMPONI, a human monoclonal antibody targeting TNF-alpha, is notable for being the first subcutaneous anti-TNF-alpha treatment administered every four weeks. It's approved for adults with moderate to severe UC and is in trials for pediatric use.

Vedolizumab (ENTYVIO) targets the alpha 4 beta 7 integrin to inhibit white blood cell infiltration in gut tissues, playing a crucial role in reducing inflammation in UC and Crohn's disease. Approved in both IV and SC formulations, it serves patients unresponsive or intolerant to conventional therapies.

VELSIPITY, discovered by Arena Pharmaceuticals, is an oral S1P receptor modulator designed for optimized efficacy and safety. It treats immune-mediated inflammatory diseases, including UC, with a focus on patients unresponsive to other treatments.

SKYRIZI's recent FDA approval for moderately to severely active UC in adults marks a significant milestone, extending its reach to around 1 million patients in the U.S. This approval makes SKYRIZI the first IL-23 inhibitor approved for both UC and Crohn's disease. The medication is designed for home administration via an on-body injector, enhancing patient convenience.

The UC treatment market is highly competitive, with numerous companies conducting clinical trials to develop better therapies. The pipeline includes promising drugs like TREMFYA, ABX464, BT-11 (Omilancor), PRA023, and SHR0302 (Ivarmacitinib), which are expected to significantly influence the market upon approval.

TREMFYA, another IL-23 inhibitor developed by Janssen, has shown positive results in Phase III trials, achieving high rates of endoscopic remission. SHR0302, an oral JAK1 inhibitor by Reistone Biopharma, aims to offer a safer alternative to pan-JAK inhibitors, minimizing associated side effects.

The anticipated introduction of these new therapies is expected to transform the UC market, driving growth and innovation. DelveInsight projects that the market size for ulcerative colitis will grow from USD 8.4 billion in 2023, with a significant compound annual growth rate (CAGR) by 2034. This expansion will likely attract new entrants, increasing competition and pushing forward medical advancements.