Pfizer’s oral drug, Velsipity (etrasimod), recently received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of active moderate to severe cases of ulcerative colitis (UC). With the approval, the drug will increase the competition in the UC market, where multiple players already intensively compete for their market shares, says GlobalData, a leading data and analytics company.

The approval marks a significant milestone for the American pharmaceutical company in the field of UC, following the approval by the FDA in October 2023 and the EMA approval in February 2024. The UK approval was attributed primarily to the promising results released from both the ELEVATE 12 UC and ELEVATE 52 UC studies, which demonstrated the achievement of clinical remission, with secondary endpoints being met.

Filippos Maniatis, Healthcare Analyst at GlobalData, comments: “There is indeed a need for improved therapies in the field of UC, and the recent approval of Velsipity in the UK brings further hope to patients with UC. Velsipity may be able to address unmet needs in the field, particularly as it is a therapy with an oral route of administration, which is an attractive proposition compared to other mainstay biological treatment options such as AbbVie’s Humira (adalimumab), Janssen’s Stelara (ustekinumab), and Takeda’s Entyvio (vedolizumab).”

From a mechanism of action perspective, Pfizer’s Velsipity is a sphingosine-1-phosphate (S1P) receptor modulator that controls the inflammation occurring in the colon and rectum through limiting the movement of lymphocytes from the lymph nodes into the blood. This therapy demonstrated promising Phase III results from ELEVATE 12 UC and ELEVATE 52 UC clinical trials in which 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, were shown, respectively. These results demonstrated the efficacy of the drug, resulting in its approval.

Maniatis adds: “The results from the ELEVATE studies clearly demonstrated Velsipity’s therapeutic benefit to the patients included in the trials. Nevertheless, as Pfizer further expands its portfolio in the treatment of UC, other currently marketed therapies and possibly pipeline agents may threaten the newly approved drug’s market share.”