Phase 3 trial showed noninferiority versus lansoprazole in healing and maintenance phases
By Lori Solomon HealthDay Reporter
TUESDAY, Nov. 7, 2023 (HealthDay News) — The U.S. Food and Drug Administration has approved Voquezna (vonoprazan), a novel potassium-competitive acid blocker, as a new treatment for adults for with all grades of erosive esophagitis or erosive gastroesophageal reflux disease (GERD).
The approval is based on the results of the PHALCON-EE phase 3 trial, in which Voquezna 20 mg met the primary end point of noninferiority for complete healing by week 8 in patients with all grades of erosive GERD. The healing rate was 93 percent for Voquezna 20 mg versus 85 percent for lansoprazole 30 mg, with superior rates of healing demonstrated in a secondary end point in patients with moderate-to-severe disease at week 2 versus lansoprazole (70 percent for Voquezna 20 mg versus 53 percent for lansoprazole 30 mg). Compared with lansoprazole 30 mg, Voquezna 20 mg also demonstrated noninferiority for the mean percentage of 24-hour heartburn-free days during the healing period. Voquezna 10 mg was superior to lansoprazole 15 mg in maintaining healing at six months in all randomly assigned patients (79 percent for Voquezna 10 mg versus 72 percent for lansoprazole 15 mg).
Adverse event rates were similar for Voquezna and lansoprazole, with the most common adverse events in the healing phase (≥2 percent in the Voquezna treatment arm) being gastritis (3.0 percent for Voquezna 20 mg and 2.0 percent for lansoprazole 30 mg), diarrhea (2.0 versus 3.0 percent), abdominal distension (2.0 versus 1.0 percent), abdominal pain (2.0 versus 1.0 percent), and nausea (2.0 versus 1.0 percent). In the maintenance phase, the most common adverse events (≥3 percent in the Voquezna treatment arm) were gastritis (6.0 percent for Voquezna 10 mg versus 3.0 percent for lansoprazole 15 mg), abdominal pain (4.0 versus 2.0 percent), dyspepsia (4.0 versus 3.0 percent), hypertension (3.0 versus 2.0 percent), and urinary tract infection (3.0 versus 2.0 percent).
“This approval demonstrates Phathom’s commitment to changing the gastrointestinal treatment landscape for patients and health care providers, bringing the first major innovation to the U.S. erosive GERD market in over 30 years,” Terrie Curran, president and CEO of Phathom, said in a statement.
Approval of Voquezna was granted to Phathom Pharmaceuticals.
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