Home » FDA Approves Phathom’s Two NDAs for Stomach Bacterial Infections
FDA Approves Phathom’s Two NDAs for Stomach Bacterial Infections
Phathom Pharmaceuticals has gained FDA approval for two new combination drug products for the treatment of adult patients with stomach infections caused by the bacteria, Helicobacter pylori (H. pylori), which can cause ulcers.
The two products combine an acid suppressant, vonoprazan, with antibiotic drugs. Voquezna Dual Pak combines vonoprazan and amoxicillin, while Voquezna Triple Pak combines vonoprazan, amoxicillin and clarithromycin.
The approvals were supported by results of a study of 1,046 participants that showed noninferiority of the Voquezna treatments compared with the combination therapy, lansoprazole, clarithromycin and amoxicillin.
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