Vonoprazan fumarate: Phase III data

A double-blind, Japanese Phase III trial in 607 patients with healed erosive esophagitis showed that once-daily 10 and 20 mg oral TAK-438 as maintenance treatment each met the primary endpoint of non-inferiority to once-daily 15 mg lansoprazole in the proportion of patients with endoscopically confirmed erosive esophagitis recurrence at week 24 (5.1% and 2%, respectively, vs. 16.8%, p<0.0001 for non-inferiority for both). Additionally, a post hoc analysis showed that both doses of TAK-438 were superior to lansoprazole on the endpoint at week 24 (p=0.0002 and p<0.0001, respectively). The most common treatment-emergent adverse event reported was nasopharyngitis. The data were presented at the Digestive Disease Week meeting in Chicago and were included in an NDA that Takeda submitted in Japan for TAK-438 to treat acid-related diseases in February. Takeda said it expects a response in Japan by the end of 1Q15, but declined to disclose plans for regulatory submissions in other countries. ...