Pfizer seeks to put etrasimod first
Better than Zeposia and monoclonal antibodies, and safer than Rinvoq. This appears to be Pfizer’s argument for etrasimod in ulcerative colitis – not just for the project's approval but for its use ahead of other novel agents. Two studies make up the registrational Elevate UC programme, and data put etrasimod’s efficacy ahead of Bristol Myers Squibb’s rival oral S1P inhibitor Zeposia, as well as Humira, Entyvio and Stelara. True, trial designs differ widely, confounding cross-comparisons to an even greater degree than normal, but bullish SVB Securities analysts believe that trial design likely understates etrasimod’s efficacy. Etrasimod could have another edge over Zeposia in that the latter needs to be titrated and carries a label warning regarding bradyarrhythmia and certain cardiac contraindications. While there were three cases of bradycardia leading to discontinuation in the UC 12 induction trial of etrasimod, these were not considered serious adverse events, and there were none in the UC 52 maintenance trial. A superior label and prime positioning is presumably what Pfizer had in mind when it paid $6.7bn for Arena, though whether this is achievable will come down to the FDA. Regulatory filings will be initiated later this year.