HomeMarket NewsPhathom files for FDA approval of vonoprazan for Non-Erosive GERD

Phathom files for FDA approval of vonoprazan for Non-Erosive GERD

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FDA Made of Colurful Pills and Drugs


Phathom Pharmaceuticals (NASDAQ:PHAT) has submitted its application to the FDA for the approval of vonoprazan. The drug is intended to be used on a daily basis for the treatment of non-erosive gastroesophageal reflux disease, commonly known as non-erosive GERD.

The biopharmaceutical company anticipates that the FDA will make its decision on the drug’s approval in the third quarter.

The company also revealed that it is initiating a Phase 3 study to evaluate the effectiveness of vonoprazan as an β€œas needed” treatment for heartburn episodes associated with non-erosive GERD.

Currently, the FDA is reviewing the use of the drug for erosive GERD and is expected to announce its decision by November 17. If approved, Phathom plans to launch the product in the fourth quarter.

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