Phathom Pharmaceuticals announces FDA acceptance for filing VOQUEZNA NDA

Phathom Pharmaceuticals announced the FDA has accepted for review the company’s NDA for VOQUEZNA as a daily treatment of heartburn associated with Non-Erosive gastroesophageal reflux disease, GERD, in adults. The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act, PDUFA, target action date of July 19, 2024. “Today marks an important step forward for Phathom Pharmaceuticals as we announce the FDA’s acceptance for filing of our New Drug Application for VOQUEZNA as a daily treatment of heartburn for patients with Non-Erosive GERD,” said Azmi Nabulsi, M.D., Chief Operating Officer at Phathom. “Non-Erosive GERD represents a substantial segment of the U.S. GERD population, affecting millions of individuals and impacting their quality of life. The supportive data in our regulatory application include the positive Phase 3 results from the investigational PHALCON-NERD-301 trial, along with a safety profile consistent with prior studies. We look forward to working closely with the FDA throughout the review process and if approved, expect to launch VOQUEZNA for this new indication in the third quarter of 2024.”