In a significant milestone, the U.S. Food and Drug Administration (FDA) has greenlit Phathom Pharmaceuticals’ revolutionary therapy, Voquezna (vonoprazan), heralding a new era in the treatment landscape for erosive esophagitis (EE) and gastroesophageal reflux disease (GERD) among adults.
The nod comes on the heels of the PHALCON-EE Phase III trial, where Voquezna 20 mg showcased not only efficacy but marked non-inferiority in achieving complete healing within the crucial 8-week window for patients across all severity levels of erosive GERD.
Impressively, Voquezna’s cure rate at 93% outshone the 85% rate for lansoprazole 30 mg. Notably, for patients with moderate to severe conditions, Voquezna 20 mg demonstrated a robust secondary endpoint healing rate of 70%, surpassing lansoprazole 30 mg at 53% by the second week.
Beyond the healing phase, Voquezna 20 mg continued to exhibit non-inferiority in maintaining healing, particularly evident in the average percentage of 24-hour heartburn-free days compared to lansoprazole 30 mg. In a noteworthy outcome, Voquezna 10 mg showcased superior performance over 15 mg in sustaining healing over a remarkable 6-month period.
Adverse event profiles for Voquezna and lansoprazole mirrored each other, with common events during the healing period including gastritis, abdominal distension, abdominal pain, and nausea.
Throughout the maintenance treatment stage, Voquezna’s adverse events remained comparable, with gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infections among the most frequent.
Terrie Curran, Phathom’s President, and CEO expressed,”This approval marks Phathom’s dedication to revolutionizing gastrointestinal therapy, ushering in the first significant innovation in the U.S. market for erosive GERD in over 30 years.” Voquezna’s FDA approval indeed stands as a beacon of transformative progress in the realm of GERD treatment, setting the stage for a new paradigm in patient-centric digestive health.
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