FDA approves Voquezna to treat erosive esophagitis, gastroesophageal reflux disease

The U.S. Food and Drug Administration has approved Phathom Pharmaceuticals’ Voquezna (vonoprazan), a novel potassium-competitive acid blocker, as a new treatment for adults with various degrees of erosive esophagitis, or erosive gastroesophageal reflux disease (GERD) method.

The approval is based on results from the PHALCON-EE Phase III trial, in which Voquezna 20 mg met the primary endpoint of complete healing at week eight in patients with all grades of erosive GERD.

Voquezna 20 mg had a cure rate of 93% and lansoprazole 30 mg 85%, with secondary endpoints showing higher cure rates in patients with moderate to severe disease at week two compared with lansoprazole (Voquezna 20 mg was 70%) for lansoprazole 30 mg and 53%).

Voquezna 20 mg also demonstrated non-inferiority compared to lansoprazole 30 mg in the mean percentage of 24-hour heartburn-free days during the healing period. Among all randomized patients, Voquezna 10 mg was superior to lansoprazole 15 mg in maintaining healing after six months (79% for Voquezna 10 mg and 72% for lansoprazole 15 mg).

The incidence of adverse events was similar between Voquezna and lansoprazole, with the most common adverse events during the healing phase (≥2% in the Voquezna treatment group) being gastritis (3.0% for Voquezna 20 mg and 2.0% for lansoprazole 30 mg), diarrhea (3.0% for Voquezna 20 mg and 2.0% for Lansoprazole 30 mg), diarrhea (2.0 vs 3.0%), bloating (2.0 vs 1.0%), abdominal pain (2.0 vs 1.0%), and nausea (2.0 vs 1.0%) .

During the maintenance phase, the most common adverse events (≥3% in the Voquezna treatment group) were gastritis (6.0% for Voquezna 10 mg and 3.0% for lansoprazole 15 mg), abdominal pain (4.0% vs. 2.0%), dyspepsia ( 4.0%) 3.0% vs. 3.0%), hypertension (3.0% vs. 2.0%), and urinary tract infection (3.0% vs. 2.0%).

Terrie Curran, president and CEO of Phathom, said in a statement: “This approval demonstrates Phathom’s commitment to changing the gastrointestinal treatment landscape for patients and healthcare providers, bringing 30% of the U.S. erosive gastroesophageal reflux disease market. The first major innovation in years.”