Vonoprazan fumarate: Phase III data

A double-blind, double-dummy, Japanese Phase III trial in 650 H. pylori-positive patients with scarred gastric or duodenal ulcers showed that first-line treatment with twice-daily 20 mg oral TAK-438 plus amoxicillin and clarithromycin for 1 week met the primary endpoint of non-inferiority to twice-daily 30 mg lansoprazole plus amoxicillin and clarithromycin for 1 week in the eradication rate of H. pylori 4 weeks after completion of treatment (92.6% vs. 75.9%, p<0.0001 for non-inferiority). Additionally, the TAK-438 regimen was superior to the lansoprazole regimen on the endpoint 4 weeks after completion of treatment (p<0.0001). Six patients reported serious treatment-emergent adverse events with 1 case of acute myocardial infarction (MI) assessed as related to TAK-438. The most common treatment-emergent adverse events reported were diarrhea, nasopharyngitis and dysgeusia. 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. ...