Pfizer scores EU nod for ulcerative colitis drug Velsipity
19 Feb 2024
Clinical ResultPhase 3Drug ApprovalBiosimilar
The European Commission has approved Pfizer's S1P receptor modulator Velsipity (etrasimod) for patients 16 years and older with moderate-to-severe active ulcerative colitis (UC) who haven't responded well to traditional treatments or biological agents, or who couldn't tolerate them.
Séverine Vermeire, an investigator in the ELEVATE registrational programme, suggested the once-daily oral medicine could provide an effective advanced treatment for those who may be apprehensive about using injectable therapies such as biologics.
Velsipity recently passed muster with the European Medicines Agency's drug advisory body based on data from the Phase III ELEVATE UC 12 and ELEVATE UC 52 trials, both of which met all primary and key secondary efficacy endpoints. The studies involved UC patients who had previously failed or were intolerant to at least one conventional, biologic or JAK inhibitorJAK inhibitor therapy.
Clinical remission in ELEVATE UC 12 was achieved among 26% of patients receiving Velsipity compared to 15% for placebo. In ELEVATE UC 52, the clinical remission rate was 27% with Pfizer's drug at week 12, and 32% at week 52, compared to 7% at both timepoints for placebo. Key secondary efficacy goals such as endoscopic improvement and mucosal healing were also achieved.
Hitting the 'sweet spot' with S1Ps
Velsipity was approved in the US for the same indication last October, and more recently in Canada. Regulatory applications have also been submitted in several other markets, including Australia, India, Mexico, Russia, Singapore, Switzerland, Turkey and the UK.
The EU's Velsipity nod follows the approval of Bristol Myers Squibb's S1P receptor modulator Zeposia (ozanimod) for UC in 2021. In a recent FirstWord interview, a key opinion leader (KOL) suggested the "sweet spot" for S1Ps will likely be in moderate patients who have failed mesalamine and may have required one or two courses of steroids. "It probably does not play a role in those who have failed multiple biologics."
The expert also predicted that Velsipity will probably dominate the S1P market within a year or two, although drugs in the class may face some competition from biosimilar versions of Johnson & Johnson's Stelara (ustekinumab) if the price difference is significant enough.
Johnson & Johnson is bracing for the first biosimilars of its autoimmune blockbuster to come on the scene this year with Alvotech's contender AVT04 expected to enter the market in Canada, Japan and Europe, while a US launch for the biosimilar rival is planned for early 2025.
Johnson & Johnson is bracing for the first biosimilars of its autoimmune blockbuster to come on the scene this year with Alvotech's contender AVT04 expected to enter the market in Canada, Japan and Europe, while a US launch for the rival is planned for early 2025.
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