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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