Phath­om notch­es FDA ap­proval for Vo­quez­na to treat ero­sive GERD

The FDA on Thurs­day ap­proved Phath­om Phar­ma­ceu­ti­cals’ potas­si­um-com­pet­i­tive acid block­er Vo­quez­na (vono­prazan) to treat ero­sive gas­troe­sophageal re­flux dis­ease (GERD), of­fer­ing a new class of treat­ment for the dis­ease.

The ap­proval is based on pos­i­tive Phase III re­sults from PHAL­CON-EE, a ran­dom­ized dou­ble-blind, mul­ti-cen­ter study that en­rolled 1,024 par­tic­i­pants. The ap­proval of this in­di­ca­tion for GERD comes af­ter the FDA on Mon­day ap­proved the re­for­mu­la­tion of Vo­quez­na for the treat­ment of the bac­te­r­i­al in­fec­tion H. py­lori, which comes in packs with cor­re­spond­ing an­tibi­otics.

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