FDA Accepts Phathom Pharmaceuticals' Resubmission for Vonoprazan

By Dean Seal

Phathom Pharmaceuticals said the U.S. Food and Drug Administration has accepted its resubmission of a new drug application for vonoprazan as a treatment for erosive gastroesophageal reflux disease, or GERD.

The gastrointestinal disease-focused biopharmaceutical company said regulators acknowledged that the refiled application constituted a complete response to the FDA's complete response letter from February.

The agency said in February that Phathom needed to provide additional stability data to demonstrate that levels of an impurity previously found in vonoprazan will remain at or below the daily acceptable intake throughout the proposed shelf life of the product.

Phathom's resubmission contained three months of stability data for reformulated vonoprazan tablets to support the drug's commercial shelf life. The company said it will continue to provide stability data throughout the regulatory review.

The FDA has classified the latest new drug application as a Class 2 resubmission and set a Prescription Drug User Fee Act goal date of Nov. 17.

"This significant milestone brings us one step closer to the approval of a new class of treatment for Erosive GERD representing the first major innovation to the U.S. GERD market in over 30 years," Chief Executive Terrie Curran said.

Shares advanced 2.4% to $13.30 in premarket trading.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

June 12, 2023 08:49 ET (12:49 GMT)

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