The recent approval of Pfizer’s oral drug, Velsipity (etrasimod), by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for active moderate to severe cases of ulcerative colitis (UC) marks a significant milestone for the American pharmaceutical company in the field of UC. Specifically, UC patients in the UK aged 16 or older with poor response or intolerance to previous UC treatments will now have access to Pfizer’s newly approved drug. This decision comes after Velsipity’s recent approval by the FDA in October 2023 for the US, followed by the EMA approval in February 2024 for the EU. The promising results released from the ELEVATE 12 UC and ELEVATE 52 UC studies demonstrated the achievement of clinical remission, with secondary endpoints being met, contributing to the regulatory agency giving the green light for its approval. Nevertheless, as Pfizer further expands its portfolio in the treatment of UC, the competition in the market increases, with other currently marketed therapies and possibly pipeline agents threatening the newly approved drug’s market share.

UC is a chronic condition and a form of inflammatory bowel disease (IBD), characterised by inflammation of the colon and rectum. UC affects the inner lining of the large intestine, leading to ulceration, and consequently to life-threatening complications. Recent studies conducted by Crohn’s and Colitis UK estimate that more than one in 123 people in the UK suffer from an IBD condition. In addition, the chronic nature of the disease, which demands ongoing medical care, increases healthcare costs, with severe cases in relapse reaching an annual cost of around $13,600 for the NHS, further highlighting the need for advanced therapies for UC. Pfizer’s Velsipity is a sphingosine-1-phosphate (S1P) receptor modulator that limits the movement of lymphocytes from the lymph nodes into the blood, therefore reducing inflammation. With Pfizer’s Velsipity Phase III results from ELEVATE 12 UC and ELEVATE 52 UC clinical trials demonstrating a clinical remission of 26.0% at Week 12, and 32.0% at Week 52, for patients receiving etrasimod, compared to 15.0% and 7.0% for patients receiving placebo, respectively, the drug has now been added to the treatment options for people in the UK.

The UC treatment field is highly competitive, with multiple drugs approved for patients with moderate to severe active UC. While biologic therapies such as AbbVie’s Humira (adalimumab), Janssen’s Stelara (ustekinumab), and Takeda’s Entyvio (vedolizumab) represent mainstay treatment options for these patients, oral therapies remain an attractive option due to their route of administration. Examples of the latter include Pfizer’s Xeljanz (tofacitinib) and Bristol Myers Squibb’s Zeposia (ozanimod). GlobalData estimates that by 2031, interleukin inhibitors, S1P modulators, and TNF inhibitors are anticipated to generate $2.0bn, $797.4m, and $1.3bn respectively, across the eight major markets (US, France, Germany, Italy, Spain, UK, Japan, Canada).

Among late-stage pipeline agents, AbbVie’s Skyrizi (risankizumab) is currently in the pre-registration stage in the US, the EU, and Japan; Johnson & Johnson’s Tremfya (guselkumab) is also in pre-registration stage in the US. These pipeline agents are expected to be key players in the treatment landscape of UC, upon their approval, as both have shown promising preliminary Phase III results. With the latest approval, Pfizer’s Velsipity can expect direct competition from Bristol Myers Squibb’s Zeposia on the basis that both therapies have similar mechanisms of action and routes of administration.

While the approval of Pfizer’s Velsipity in the UK brings hope to UC patients as treatment options expand, there is also an anticipation that pipeline agents in development for UC are eventually able to address the need for highly efficacious treatment alternatives should these agents receive approval.