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Phathom Pharmaceuticals Submits Two NDAs to U.S. FDA for Vonoprazan-based Treatment Regimens for the Treatment of H. pylori Infection
FLORHAM PARK, N.J., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":"FLORHAM PARK, N.J., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that it has submitted two new drug applications (NDAs) to the U.S. Food and Drug Administration (FDA) for the use of vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan in combination with amoxicillin (vonoprazan dual therapy) as a treatment for Helicobacter pylori (H. pylori) infection in adults. With current standard of care therapies, H. pylori eradication rates have declined in the U.S. If approved, vonoprazan-based treatments offer two new therapeutic options that have demonstrated superior eradication rates as compared to standard of care lansoprazole-based triple therapy. “The submission of these NDAs is the first step towards addressing the declining H. pylori eradication rates in the U.S. and providing new potential treatment options for the millions of H. pylori sufferers in need of more efficacious treatments,” said Azmi Nabulsi, M.D., Chief Operating Officer at Phathom. “Today’s announcement underscores Phathom’s commitment to changing the treatment landscape for acid-related diseases. If approved, patients and healthcare providers would have two novel options to combat this highly prevalent bacterial infection. We look forward to working with the FDA to advance these vonoprazan-based treatment regimens toward approval. If approved, we anticipate launch in the U.S. in the second half of 2022.” These NDAs are based on the positive data previously announced from Phathom’s pivotal Phase 3 PHALCON-HP trial, the largest U.S. registrational trial ever conducted for H. pylori. The study evaluated eradication rates of H. pylori infection using vonoprazan triple therapy and vonoprazan dual therapy compared to lansoprazole-based triple therapy. Vonoprazan triple therapy and vonoprazan dual therapy successfully met the study’s primary non-inferiority endpoints and all secondary endpoints, demonstrating superior eradication rates versus lansoprazole-based triple therapy among all patients including in patients with clarithromycin resistant strains of H. pylori. The FDA has previously designated vonoprazan triple therapy and vo...