FDA Accepts Review Of Phathom Pharmaceuticals' NDA For Vonoprazan

The Food and Drug Administration (FDA) has accepted for review Phathom Pharmaceuticals’ PHAT New Drug Application (NDA) of its lead drug candidate Vonoprazan for the healing of all grades of erosive esophagitis (EE).

The regulatory agency has assigned standard review for the application and set a target action date of January 11, 2023.

The new drug application is supported by positive data readout from Phase 3 PHALCON-EE clinical trial, that enrolled 1,027 patients with erosive esophagitis (EE).

Also Read: Elevation Oncology Shares Gain On FDA Fast Track Designation For Seribantumab In Tumor-Agnostic Settings

Azmi Nabulsi, M.D., and chief operating officer, said, “With this NDA filing, we are excited about our potential to offer a treatment option to address the significant unmet needs that exist for the millions of patients suffering from painful erosions caused by all grades of EE.”

Erosive esophagitis (EE) is a major type of gastroesophageal reflux disease (GERD) and affects approximately 20 million people in the United States.

Phathom Pharmaceuticals shares are trading lower by 5.38% at $7.39 on Wednesday, according to Benzinga Pro.