Phathom Pharmaceuticals, Inc. already launched the heartburn reliever Voquezna (vonoprazan) in November 2023, but US Food and Drug Administration approval in an expanded indication will make the treatment available to a substantially larger set of patients. The FDA approved Voquezna on 17 July for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) in adults, a condition that affects millions of individuals.
Key Takeaways
- CEO Terrie Curran talked to Scrip in an interview about the launch of Voquezna, the first new mechanism of action for GERD in decades.
- Phathom has a goal to displace commonly used proton pump inhibitors as the treatment of choice for GERD
The approval marks the third indication for Voquezna, a first-in-class potassium-competitive acid blocker (PCAB) that FDA originally approved in 2022 for treating Heliobacter pylori infections in combination with antibiotics. (Also see "Phathom’s First Approval Of Voquezna Expected To Lay Ground For Larger Indications" - Scrip, 4 May, 2022.) The commercial launch was delayed, however, due to manufacturing impurities, and a reformulated version of the drug received FDA approval in November 2023, along with a new indication for erosive esophagitis, also referred to as erosive GERD
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