Vonoprazan fumarate: Phase III data

A double-blind, Japanese Phase III trial in 409 patients with erosive esophagitis showed that once-daily 20 mg oral TAK-438 met the primary endpoint of non-inferiority to once-daily 30 mg lansoprazole in the proportion of patients with endoscopically confirmed healing of erosive esophagitis at week 8 (99% vs. 95.5%, p<0.0001 for non-inferiority). Additionally, a post hoc analysis showed that TAK-438 was superior to lansoprazole on the endpoint at week 8 (p=0.0337). 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. ...