The approval was based on the safety and efficacy data from the phase 3 PHALCON-HP trial in which both VOQUEZNA therapy regimens showed non-inferiority to lansoprazole triple treatment
A microscopic image of H. pylori colonised on the surface of regenerative epithelium. (Credit: Yutaka Tsutsumi, M.D. Professor Department of Pathology from Wikimedia Commons)
Phathom Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Prior Approval Supplement (PAS) to reformulate vonoprazan tablets for the treatment of adults with Helicobacter pylori (H. pylori) infection.
The FDA has approved the reformulation of vonoprazan tablets for both Voquezna Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and Voquezna Dual Pak (vonoprazan tablets, amoxicillin capsules).
The Voquezna therapy regimens include antibiotics packaged with vonoprazan, a potassium-competitive acid blocker (PCAB), and the first novel acid suppressant from a new drug class licensed in the US in the last 30 years.
These initial product approvals from the American health regulator were supported by safety and efficacy data from the Phase 3 PHALCON-HP trial.
In the modified intent-to-treat population, both Voquezna therapy regimens showed non-inferiority to lansoprazole triple treatment in patients who do not have a clarithromycin or amoxicillin-resistant strain of H. pylori at baseline.
According to the results, the H. pylori eradication rate was observed at 84.7% with Voquezna Triple Pak against 78.8% with lansoprazole triple therapy.
In addition, the rate was found at 78.5% for Voquezna Dual Pak against 78.8% with lansoprazole triple therapy.
Voquezna Triple Pak and Dual Pak displayed better eradication rates in comparison to PPI-based triple therapy among all patients.
Phathom president and CEO Terrie Curran said: “We are very pleased with the FDA approval of our reformulated vonoprazan tablets for both Voquezna Triple Pak and Voquezna Dual Pak, enabling Phathom to market two new first-line treatment options that offer strong H. pylori eradication rates.
“H. pylori eradication failures are due to rising antibiotic resistance, inadequate acid suppression, and complex treatment regimens. We are excited about voquezna triple and dual Paks, a new class of acid suppression therapy, that has the potential to address these issues and enhance H. pylori eradication.”
Phathom will be the exclusive marketer of Voquezna Triple and Dual Paks which are anticipated to be available in the US in December 2023.
If authorised, the pharmaceutical firm intends to introduce vonoprazan for erosive GERD along with Voquezna Triple Pak and Voquezna Dual Pak for commercial use in the US.