Posted by Michael Wonder on 24 May 2023
Phathom Pharmaceuticals resubmits erosive GERD new drug application to FDA
23 May 2023 - Anticipated FDA action date in Q4, 2023; if approved, combined launch for erosive gastro-oesophageal reflux disease and H. pylori indications planned before year end.
Phathom Pharmaceuticals today announced that it has resubmitted its new drug application for vonoprazan, a novel first in class potassium-competitive acid blocker, for the treatment of erosive gastro-oesophageal reflux disease, also referred to as erosive oesophagitis, to the US FDA.
