FDA expands Voquenza tablet approval for heartburn in non-erosive GERD patients.

FDA expands approval of Phathom Pharmaceuticals' Voquenza tablets to alleviate heartburn for non-erosive GERD. This is the third approved indication for Voquenza, which is also approved to treat all severities of erosive esophagitis and in combination with antibiotics for the eradication of Helicobacter pylori infection. The approval is supported by results from a phase 3 randomized, placebo-controlled, double-blind, multicenter study evaluating the safety and efficacy of Voquenza in over 700 adults with non-erosive GERD experiencing at least 4 days of heartburn per week.

July 18, 2024
8 Articles

Further Reading