A meeting with the FDA has paved the way for Phathom Pharmaceuticals to resubmit its applications for its erosive esophagitis and Helicobacter pylori drug Voquezna, the company said on Tuesday.
Shortly after Voquezna won approval last May to treat H. pylori, the company found trace levels of a potential cancer-causing agent in commercial batches. With that, Phathom delayed the launch.
In addition, the FDA put a hold on another potential approval for the oral treatment, in erosive esophagitis. That decision was due on Jan. 11 of this year.
Phathom has tapped CDMO Evonik for commercial production of Voquenza. Evonik will manufacture the drug from its sites in Europe and North America.
Two months ago, the company said that Complete Response Letters (CRLs) for that application and another for a post-approval supplemental license for H. pylori were issued by the FDA.
The CRLs asked Phathom to generate additional stability data showing that levels of the nitrosamine N-nitro-vonoprazan (NVP) would consistently remain at or below a daily acceptable intake level of 96 nanograms.
Nitrosamines have been a thorny issue for several drugmakers in recent years. The compounds, which are found in everyday items such as water and food, have triggered large recalls, shortages and product pulls across the industry, most notably with heartburn drug Zantac.
Since the discovery, New Jersey-based Phathom has conducted “extensive” root-cause investigations and implemented mitigation measures, the company said in a press release on Tuesday. Those include a “minor tablet” reformulation of Voquezna to inhibit the growth of NVP, the company added.
Phathom has shared stability data with the FDA on its new formulation and received feedback from the regulator on how to proceed with its submissions, it said. The company expects to resubmit the applications by the end of this quarter, with the launch of Voquezna in both indications targeted for the fourth quarter.
H. pylori typically affects the stomach or the small intestine. Voquezna comes in two versions. The Dual Pak consists of vonoprazan, a novel potassium-competitive acid blocker with antibiotic amoxicillin. The Triple Pak versio adds clarithromycin to the mix.
Erosive esophagitis is a severe form of acid reflux in which the lining of the esophagus is damaged by the backup of stomach acid. Once the esophagus is eroded, it can take up to nine months of treatment for it to heal.
Voquenza is the lone approved product for Phathom, which was spun out of Takeda in 2019. The Japanese parent already was selling the drug in Asia before it was endorsed by the FDA. A planned third quarter launch was derailed by the discovery of the impurity.