Phathom Pharmaceuticals Inc. said it has submitted two new drug applications to the U.S. Food and Drug Administration for the use of vonoprazan in combination with amoxicillin and clarithromycin and vonoprazan in combination with amoxicillin as a treatment for Helicobacter pylori infection in adults.
The biopharmaceutical company said that if approved, vonoprazan-based treatments will offer two new therapeutic options that have demonstrated superior eradication rates as compared to standard of care lansoprazole-based triple therapy.
If approved, the company expects to launch the treatments in the U.S. in the second half of 2022.
The new drug applications are based on positive data previously announced from Phathom's Phase 3 trial for H. pylori, the company said. 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 vonoprazan dual therapy as qualified infectious disease products and awarded them fast track designation.
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