- Phathom Pharmaceuticals Inc PHAT has resubmitted its marketing application to the FDA for approval of vonoprazan, intended for the treatment of Erosive GERD (gastroesophageal reflux disease), which is also known as erosive esophagitis.
- The resubmission comes in response to the Complete Response Letter issued by the FDA in February 2023 with concerns about specifications and controls for a nitrosamine drug substance-related impurity known as N-nitroso-vonoprazan (NVP).
- The resubmission includes three months of stability data for six batches of reformulated vonoprazan tablets. These data demonstrate that Phathom’s mitigation measures successfully control NVP growth through three months, maintaining levels significantly below the acceptable daily intake limit of 96 ng/day.
- All manufactured batches of the reformulated tablets have demonstrated adequate control of NVP through three months of stability testing, exceeding regulatory requirements and providing support for the requested 24-month shelf life.
- Phathom anticipates that the application will be categorized as a Class 2 resubmission with a six-month review period and intends to provide the FDA with another six months of stability data from its ongoing program during the regulatory review process.
- Pending approval, a combined US commercial launch for the Erosive GERD and H. pylori indications is scheduled for the fourth quarter of 2023.
- Phathom raised $130.7 million through an equity offering of 11.125 million shares at $11.75 per share concurrently with the resubmission.
PHAT Price Action: Shares of Phathom Pharmaceuticals (PHAT) have decreased by 11.23% to $11.60 as of Wednesday at publication time.
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