The FDA has approved two of Phathom Pharmaceuticals’ products for bacterial illnesses in adults: Voquezna Triple Pak and Voquezna Dual Pak.
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Phathom Pharmaceuticals is having a good week as the U.S. Food and Drug Administration approved two of its products for bacterial illnesses in adults.
Voquezna Triple Pak and Voquezna Dual Pak were both given the green light to treat Helicobacter pylori (H. pylori). The products’ New Drug Applications had been granted priority review and also designated as Qualified Infectious Diseases Products.
Voquezna Triple Pak is made up of vonoprazan tablets, amoxicillin capsules and clarithromycin tablets, while the Dual Pak consists of vonoprazan tablets and amoxicillin capsules. Both are designed to address the H. pylori bacterial pathogen, which can lead to serious complications like non-cardia gastric cancer and peptic ulcer if left untreated. There are around 115 million people affected by this pathogen in the U.S. and eradication rates are below 80%.
Vonoprazan, a potassium-competitive acid blocker, is the first innovative acid suppressant from a new drug classification in the U.S. over the last three decades.
The FDA’s decision is based on stellar results from the Phase III PHALCON-HP trial, which covered 1,046 patients with H. pylori.
Both treatment regimens demonstrated non-inferiority to lansoprazole triple therapy with no clarithromycin or amoxicillin resistant strain of the bacterium at baseline. Triple Pak demonstrated an 84.7% eradication rate versus 78.8% in the lansoprazole group, while Dual Pak showed a 78.5% eradication rate compared to lansoprazole triple’s 78.8%.
Among the same patients, including those with clarithromycin-resistant strains of H. pylori, Voquezna Triple Pak logged an 80.8% eradication rate compared to 68.5% in lansoprazole with amoxicillin and clarithromycin. Those who received a Dual Pak logged 77.2% versus 68.5%.
Some adverse events were observed but were not much different from the AEs seen in lansoprazole triple therapy arms, such as dysgeusia, diarrhea, hypertension, abdominal pain, vulvovaginal candidiasis and nasopharyngitis.
Phathom notes that both products are not recommended for patients with hypersensitivity to amoxicillin or vonoprazan, other beta-lactams and those receiving drugs that contain rilpivirine. The clarithromycin component also makes them contraindicated in those with allergies to the drug or other similar antibiotic, those with a history of hepatic dysfunction and others.
“H. pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression and complex treatment regimens, resulting in treatment failures and complications for patients. New therapies that have the potential to address the limitations of current treatments are needed and we look forward to bringing these innovative vonoprazan-based treatment options to the millions of H. pylori sufferers in the U.S.,” Terri Curran, president and chief executive officer of Phathom, said in a statement.
Voquezna Triple Pak and Voquezna Dual Pak will be out in the U.S. market by the third quarter of 2022. Phathom will be marketing the products exclusively.
