Phathom Pharmaceuticals Receives 2 FDA Approvals For Voquezna (Vonoprazan) in Q3 2023
Scoring two FDA wins in three days is uncommon. Nonetheless, Phathom Pharmaceuticals celebrated this accomplishment for its first-in-class heartburn drug.
The FDA on October 30 signed off on Phathom’s reformulation of Voquezna (vonoprazan) for Helicobacter pylori infection. The second approval came shortly after, on November 1. This time, it was for the drug’s capabilities to treat erosive gastroesophageal reflux disease (GERD) and associated heartburn.
These FDA approvals came late, following a delay and strict scrutiny after an unprecedented setback.
Understanding the Impurity Setback
The FDA granted in May 2022 the initial approval of the drug for the treatment of H. pylori. However, in the summer of that year, it withdrew approval when tests found traces of the nitrosamine N-nitroso-vonoprazan (NVP) in Phathom’s commercial batches.
Nitrosamines are present in water, food, and other everyday items. However, exposure to high concentrations of nitrosamines can cause cancer. Carcinogenic nitrosamine contaminants have also been present in other medications, including the heartburn drug Zantac.
In January 2023, the FDA suspended the biopharmaceutical company’s request to use the drug for treating erosive GERD. It also requested Phathom Pharmaceuticals to provide additional stability data that proves the nitrosamine levels in Voquezna remain within the daily acceptable intake limit of 96 nanograms.
The New Jersey-based company submitted new data in April, showing how its mitigation measures successfully restrained the growth of NVP.
Indications and Usage of Voquezna
Functioning as potassium-competitive acid blockers or PCAB drugs, the new vonoprazan tablets have various indications for adult patients.
They are effective in healing all grades of erosive GERD and associated heartburn. They also work with antibiotics such as amoxicillin and clarithromycin for treating H. pylori infection.
On the other hand, individuals with a documented hypersensitivity to any components of Voquezna should avoid taking this medication. The same applies to those currently taking products containing rilpivirine.
What to Expect From Phathom Next
The company announced the immediate launch of the first acid suppressant in the U.S. that outperforms proton pump inhibitors. Erosive GERD patients should be able to buy Voquezna tablets at the time of writing.
Beginning December 2023, adults with H. pylori infection can choose between two variants: The Dual Pak, which contains amoxicillin, and the Triple Pak, which includes both amoxicillin and clarithromycin.
Meanwhile, Phathom Pharmaceuticals aims for FDA approval of Voquezna in the second half of 2024 as a non-erosive GERD treatment.
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