The initial approval for Voquezna to treat H. pylori was given in May 2022 but was later revoked. Credit: Bet_Noire via Getty Images.

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.  

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.  

See Also:

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. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.