Phathom Pharmaceuticals has received two approvals within a three-day span from the US Food and Drug Administration (FDA) for the heartburn drug Voquezna (vonoprazan).
The first approval was granted on 30 October when the regulator signed off on Phathom’s reformulation of Voquezna to treat H. pylori. The second, granted on 1 November, allows Voquezna to be used for erosive gastroesophageal reflux disease (GERD) and associated heartburn.
The initial approval for Voquezna to treat H. pylori was given in May 2022 but was later revoked due to the presence of trace levels of a cancer-causing substance in commercial batches.
While dealing with these delays, the FDA also suspended Phathom’s request for the drug’s use to treat erosive GERD. In April, after receiving complete response letters (CRL) for both indications, Phathom provided stability data to the FDA from the Phase III PHALCON-EE study, which enrolled 1,024 participants. The resubmitted data showed the company’s mitigation measures were successful in curbing the growth of n-nitroso-vonoprazan, the previously detected impurity.
The company is now planning the commercial release of the potassium-competitive acid blocker in December 2023. The FDA approval has entitled Phathom to a $175m payment under the revenue interest financing agreement, which will support the drug’s launch.
With these approvals, Voquezna becomes the first acid suppressant in the US to show superiority over the standard proton pump inhibitors (PPIs) across various indications.
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By GlobalData
According to GlobalData, Voquezna is forecast to generate $1.8bn in sales in 2029. Sales for Nexium (esomeprazole), a PPI marketed by AstraZeneca, had generated $1.28bn in sales as per the company’s annual report. With increasing competition from generics and other drugs, GlobalData forecasts sales of Nexium will drop to $452m in 2029.
GlobalData is the parent company of Pharmaceutical Technology.
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