Phathom wins FDA review for resubmitted application to market heartburn drug

• Phathom Pharmaceuticals (NASDAQ:PHAT) announced Monday that the FDA accepted its resubmitted New Drug Application (NDA) for vonoprazan targeted at erosive GERD (gastroesophageal reflux disease), a GIT disorder characterized by heartburn.
• The NDA resubmission marks the company’s reply to the complete response letter issued by the agency in February, citing concerns over a nitrosamine drug substance-related impurity.
• The FDA has classified the NDA as a Class 2 resubmission and issued November 17, 2023, as the target action date for its review.
• Phathom (PHAT) expects to launch vonoprazan for both erosive GERD and H. pylori indications in Q4 2023, subject to regulatory approval.
• In May 2022, the FDA approved vonoprazan as Voquezna Triple Pak and Voquezna Dual Pak to treat Helicobacter pylori infection in adults.

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