pHalcon-EE: a phase 3 study of VOQUEZNA in Erosive GERD1
The efficacy and safety of VOQUEZNA was evaluated in a randomized, active-controlled, double-blind study conducted in the US and Europe in patients with endoscopically confirmed Erosive GERD (Erosive Esophagitis).
Vonoprazan has been approved for the treatment of Erosive GERD in Japan since 2014.2,* Data from randomized, controlled studies outside the US were supportive in obtaining approval for VOQUEZNA in the US.1
*Takeda is the marketing authorization holder for vonoprazan in Japan.
- Patients who were positive for H. pylori infection or who had Barrett’s esophagus and/or definite dysplastic changes in the esophagus at baseline were excluded from the study
- Based on the Los Angeles (LA) Classification, 66% of patients had mild Erosive GERD (Grades A or B), and 34% of patients had moderate-to-severe Erosive Esophagitis (Grades C or D) before treatment
Patients with confirmed endoscopic healing at Week 2 or Week 8 were rerandomized to the 24‑week maintenance phase.
Of the 1,024 patients in the healing phase, 878† continued into the maintenance phase.
QD=once daily.
†Represents mITT population.
‡A higher-dose VOQUEZNA treatment group not shown, although this group is included in the total number of randomized patients.3