Phathom’s impending heartburn treatement given NDA by FDA

By admin Dec17,2023

The company that focuses on remedies for gastrointestinal diseases announced on December 7 that the US Food and Drug Administration (FDA) has accepted for review its new drug application (NDA) for small molecule Voquenza as a daily treatment for adults.

The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.

“Today marks an important step forward for Phathom Pharmaceuticals as we announce the FDA’s acceptance for filing of our New Drug Application for Voquenza as a daily treatment of heartburn for patients with Non-Erosive GERD,” said Azmi Nabulsi, chief operating officer at Phathom.

Non-erosive GERD treatment

“Non-Erosive GERD represents a substantial segment of the US GERD population, affecting millions of individuals and impacting their quality of life. The supportive data in our regulatory application include the positive phase 3 results from the investigational PHALCON-NERD-301 trial, along with a safety profile consistent with prior studies.

“We look forward to working closely with the FDA throughout the review process and if approved, expect to launch Voquenza for this new indication in the third quarter of 2024.”

Non-Erosive GERD is the largest subcategory of GERD and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions. Phathom says there are an estimated 38 million US adults living with Non-Erosive GERD, of these approximately 15 million are diagnosed and treated with a prescription medicine annually.

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