October 30, 2023
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The FDA has approved the prior approval supplement for Phathom Pharmaceutical’s reformulated vonoprazan tablets for its Voquenza Triple Pak and Voquenza Dual Pak to treat adults with Helicobacter pylori infection, according to a company release.
This decision comes after the agency had rejected Phathom’s post-approval supplement for H. pylori in February, citing the presence of nitrosamine impurities. The FDA had requested that the company provide “additional stability data to demonstrate that levels” of the impurity would remain at or below the daily acceptable intake throughout the shelf life of the product.
The FDA has approved the prior approval supplement for Phathom Pharmaceutical’s reformulated vonoprazan tablets for its Voquenza Triple Pak and Voquenza Dual Pak to treat adults with Helicobacter pylori infection, according to a company release.
“We are very pleased with the FDA approval of our reformulated vonoprazan tablets for both Voquenza Triple Pak and Voquenza Dual Pak, enabling Phathom to market two new first-line treatment options that offer strong H. pylori eradication rates,” Terrie Curran, president and CEO of Phathom, said in the press release. “H. pylori eradication failures are due to rising antibiotic resistance, inadequate acid suppression and complex treatment regimens. We are excited about Voquenza Triple and Dual Paks, a new class of acid suppression therapy, that has the potential to address these issues and enhance H. pylori eradication.”
Both Voquenza treatment regimens contain antibiotics combined with vonoprazan, a novel potassium-competitive acid blocker and the “first innovative acid suppressant” from a new drug class approved in the U.S. in many years, the release stated.
The FDA based its decision on safety and efficacy data from the PHALCON-HP, phase 3 trial of 1,046 patients with H. pylori randomly assigned to either of the Voquenza treatment regimens or lansoprazole triple therapy.
Compared with lansoprazole triple therapy, both Voquenza regimens demonstrated non-inferiority among patients without a clarithromycin or amoxicillin resistant strain of H. pylori at baseline, the company noted. The H. pylori eradication rate with Voquenza Triple Pak and Voquenza Dual Pak was 84.7% and 78.5% compared with 78.8% for lansoprazole triple therapy.
Additionally, the Voquenza Triple and Dual Pak compared with proton pump inhibitor-based triple therapy (lansoprazole with amoxicillin and clarithromycin) exhibited superior eradication rates among patients with clarithromycin-resistant strains of H. pylori. In the overall study population, with the Voquenza Triple and Dual Pak, the eradication rate was 80.8% and 77.2%, respectively vs. 68.5% with lansoprazole triple therapy; among patients who had a clarithromycin-resistant strain of H. pylori, the eradication rate was 65.8% and 69.6%, respectively vs. 31.9%.
According to the release, the Voquenza treatment regimens had similar adverse event rates to lansoprazole triple therapy. The most common adverse events observed among the two Voquenza regimens and lansoprazole triple therapy were diarrhea (4%, 5.2%, 9.6%), dysgeusia (4.6%, 0.6%, 6.1%), vulvovaginal candidiasis (3.2%, 2%, 1.4%), abdominal pain (2.3%, 2.6%, 2.9%), headache (2.6%, 1.4%, 1.4%), hypertension (2%, 1.1%, 0.9%) and nasopharyngitis (0.3%, 2%, 0.9%).
“Our teams are making the final preparations for a combined December 2023 U.S. commercial launch for H. pylori along with the anticipated launch of vonoprazan for erosive GERD, if approved,” Curran said.
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