With the approval, the drug will increase the competition in the UC market, where multiple players already intensively compete for their market shares, according to data and analytics firm GlobalData.
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 primarily attributed 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, said: “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).”
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.
It demonstrated encouraging phase 3 results in which clinical remission of 26% at week 12, and 32% at week 52, for patients receiving etrasimod, compared to 15% and 7% for patients receiving placebo, were shown.
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.”
With the latest approval, Pfizer’s Velsipity is expected to face direct competition from Bristol Myers Squibb’s Zeposia on the basis that both therapies have similar mechanisms of action and routes of administration.
On that note, Pfizer needs to further assess the market competition and patients' needs to understand Velsipity’s future in this dynamic market, GlobalData said.
Maniatis concludes: “The UC market has become highly competitive in recent years, and can be considered a very dynamic field, with multiple therapies receiving approvals for the treatment of UC. Ongoing unmet needs in the field as well as the healthcare burden of the disease highlight the need for the development of advanced therapies. There is an anticipation that pipeline agents in development for UC will eventually be able to address the need for highly efficacious treatment alternatives should these agents receive approval.”