FDA sets ac­tion date for Phath­om af­ter trace car­cino­gens led to CRL, grants As­traZeneca pri­or­i­ty re­view

Fol­low­ing a re­jec­tion in Feb­ru­ary, the FDA will take an­oth­er look at Phath­om Phar­ma­ceu­ti­cals’ gas­troe­sophageal re­flux dis­ease (GERD) treat­ment, the biotech said Mon­day.

The FDA will make its de­ci­sion on vono­prazan for ero­sive GERD by Nov. 17, Phath­om said. In Feb­ru­ary, the FDA re­ject­ed Phath­om Phar­ma­ceu­ti­cal’s ap­pli­ca­tion for vono­prazan — an acid-block­er mar­ket­ed in com­bi­na­tion with an­tibi­otics for H. py­lori as Vo­quen­za — af­ter traces of ni­trosamine im­pu­ri­ties, which are known to in­crease risk of can­cer, were found in the drug.

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