SKYRIZI’s Approval For Ulcerative Colitis Treatment Expands AbbVie’s Portfolio Across Immune-mediated Inflammatory Diseases | DelveInsight

AbbVie’s rapidly expanding Humira successor, SKYRIZI, is already achieving impressive sales growth. This IL-23 inhibitor is set to capture an even greater portion of Humira’s diminishing market share with its crucial expansion into treating ulcerative colitis.

LAS VEGAS, July 15, 2024 /PRNewswire/ — Ulcerative colitis is an idiopathic inflammatory bowel disease affecting ~1.5 million patients in the US and with an unknown exact cause. It affects the colonic mucosa and is clinically characterized by diarrhea, stomach discomfort, pain, and hematochezia. The disease’s extent varies, affecting either the rectum, the splenic flexure of the left side of the colon, or the whole of the rectum and bowel.

As per DelveInsight analysis, the total ulcerative colitis diagnosed prevalent cases in the 7MM comprised approximately 3 million cases in 2023 and are projected to increase by 2034. Per analyst estimates, approximately 60% of cases accounted for moderate to severe cases of ulcerative colitis among the 7MM.

The current treatments for ulcerative colitis depend on the severity of the disease and are broadly divided into six classes, comprising conventional therapies, Anti-TNFs, Anti-integrin agents, IL-12/IL-23 dual inhibitors, S1P-receptor modulators, and JAK inhibitors.

The emergence of several mechanisms of action, like LANCL2 protein stimulators, miR-124 enhancers, tumor necrosis factor (TNF)-like ligand 1A inhibitors, toll-like receptor 9 agonists, and others will be expanding the treatment landscape of ulcerative colitis.

There have been significant advancements in treating ulcerative colitis over the years. However, safety remains a major challenge. The lack of a safer and curative treatment option severely impacts patients’ quality of life and daily activities. While current treatments are effective for some patients with ulcerative colitis, others need multiple lines of therapy, indicating a need for alternative treatments to achieve disease control. Several major pharmaceutical companies are collaborating to develop new solutions to address these issues.

Learn more about the FDA-approved ulcerative colitis drugs @ Drugs for Ulcerative Colitis Treatment

A few FDA-approved drugs for ulcerative colitis treatment include SIMPONI (Janssen Pharmaceuticals), ENTYVIO (Takeda Pharmaceuticals), OMVOH (Eli Lilly) VELSIPITY (Arena Pharmaceuticals/Pfizer), and SKYRIZI (AbbVie).

SIMPONI is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (TNF)-alpha, a protein associated with inflammation and tissue damage in chronic inflammatory diseases. It is the first subcutaneous anti-TNF-alpha treatment administered every four weeks as maintenance therapy for ulcerative colitis. Approved for treating moderately to severely active ulcerative colitis in adults, SIMPONI is also being evaluated in ongoing trials for pediatric patients with the same condition.

Vedolizumab is a humanized monoclonal antibody that targets and inhibits the alpha 4 beta 7 integrin, preventing it from binding to the intestinal mucosal addressing cell adhesion molecule 1 (MAdCAM-1). This integrin is found in a subset of circulating white blood cells that play a role in the inflammatory processes of ulcerative colitis and Crohn’s disease. By blocking the alpha 4 beta 7 integrin, vedolizumab may reduce the infiltration of these white blood cells into gut tissues.

It is currently approved as an IV and SC formulation for the treatment of moderately to severely active ulcerative colitis in adults who have not responded to, lost response to, or were intolerant to conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.

VELSIPITY (Etrasimod) is an innovative, once-daily oral medication that acts as a highly selective modulator of the sphingosine 1-phosphate (S1P) receptor. Discovered by Arena, it is designed for optimized interaction with S1P receptors 1, 4, and 5, potentially offering better efficacy and safety. Etrasimod targets specific immune cells both systemically and locally and has the potential to treat various immune-mediated inflammatory diseases, such as Crohn’s disease and ulcerative colitis.

It is currently approved by the FDA and EMA for adults with moderately to severely active ulcerative colitis who have not responded adequately, lost response, or were intolerant to conventional or advanced therapies.

Recently, on 18 June 2024, the FDA approved SKYRIZI for treating adult patients with moderately to severely active ulcerative colitis. This approval extends the drug’s reach to approximately 1 million US patients and makes SKYRIZI the first IL-23 inhibitor approved for both UC and Crohn’s disease, the two types of inflammatory bowel disease (IBD).

After a 12-week induction period, patients can self-administer the medication at home using an on-body injector device, which AbbVie’s press release describes as “designed with patients in mind.” The device attaches to the body and delivers the medication in about five minutes.

Since its approval for Crohn’s in 2022, Skyrizi has emerged as a strong competitor to Johnson & Johnson’s blockbuster drug STELARA in the IBD market. The AbbVie medication has captured a “significant share” of STELARA’s sales.

To know more about ulcerative colitis treatment options, visit @ New Treatment for Ulcerative Colitis

The ulcerative colitis market is crowded with so many companies including Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck, Mesoblast, and others are running clinical trials to improve the treatment space. The ulcerative colitis pipeline possesses potential drugs in mid-stage developments to be launched shortly.

Some of the promising drugs in the pipeline include TREMFYA, ABX464, BT-11 (Omilancor), PRA023, Remestemcel-L, SHR0302 (Ivarmacitinib), and others that hold the potential to create a significant positive shift in the ulcerative colitis market size.

Discover which therapies are expected to grab major ulcerative colitis market share @ Ulcerative Colitis Market Report

TREMFYA (guselkumab) is a human monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, created by Janssen. IL-23 plays a crucial role in the pathogenesis of inflammatory diseases like ulcerative colitis and Crohn’s disease. TREMFYA, an IL-23 inhibitor, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody, produced in a mammalian cell line using recombinant DNA technology. It specifically binds to the p19 subunit of IL-23 and blocks its interaction with the IL-23 receptor.

In May 2024, Johnson & Johnson released the initial data from the Phase III QUASAR maintenance study in ulcerative colitis, which achieved its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission. Based on these findings, the company has submitted a supplemental Biologics License Application (sBLA) to the FDA.

SHR0302, developed by Reistone Biopharma, is an innovative and potent oral JAK1 inhibitor aimed at treating inflammatory bowel diseases like ulcerative colitis and Crohn’s disease. Due to its selectivity for JAK1, it may offer a safer and more effective alternative to pan-JAK inhibitors. Ongoing long-term clinical studies are investigating whether JAK1 selectivity can minimize hematological side effects associated with JAK2 inhibition, aiming to confirm a favorable risk-benefit profile (Reistone Biopharma, 2021a).

SHR0302 is currently being tested in a Phase III clinical trial (NCT05181137) for the treatment of moderate to severe ulcerative colitis in adults.

Discover more about drugs for ulcerative colitis in development @ Ulcerative Colitis Clinical Trials

The anticipated launch of these emerging therapies for ulcerative colitis are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the ulcerative colitis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

DelveInsight estimates that the market size for ulcerative colitis is expected to grow from USD 8.4 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the ulcerative colitis market, resulting in increased competition and innovation.

DelveInsight’s latest published market report titled as Ulcerative Colitis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the ulcerative colitis country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market’s underlying potential. The ulcerative colitis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

Total Diagnosed Prevalent Cases of Ulcerative ColitisAge-specific Cases of Ulcerative ColitisSeverity-specific Cases of Ulcerative ColitisTotal Treated Patients of Ulcerative Colitis

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM ulcerative colitis market. Highlights include:

11-year Forecast7MM AnalysisEpidemiology-based Market ForecastingHistorical and Forecasted Market Analysis upto 2034Emerging Drug Market UptakePeak Sales AnalysisKey Cross Competition AnalysisIndustry Expert’s OpinionAccess and Reimbursement

Download this ulcerative colitis market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs’ opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the ulcerative colitis market. Also, stay abreast of the mitigating factors to improve your market position in the ulcerative colitis therapeutic space.

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