FDA approves Phathom Pharmaceuticals’ Voquezna for erosive GERD
Phathom Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has approved Voquenza (vonoprazan) tablets 10mg and 20mg, a novel potassium-competitive acid blocker (PCAB).
The drug is approved as a treatment for adult patients for the healing of all grades of Erosive Esophagitis – also known as Erosive gastrointestinal reflux disease (GERD ) – maintenance of healing of all grades of Erosive GERD and relief associated with Erosive GERD.
The approval follows positive results from the phase 3 PHALCON-EE study, which compared Voquezna to the PPI lansoprazole for this indication. Results showed that Voquezna met its primary endpoint of non-inferiority for complete healing by week 8 in patients with all grades of Erosive GERD with a healing rate of 93% compared to 85% for lansoprazole 30mg.
The most common adverse events included: gastritis, diarrhoea, abdominal distension, abdominal pain, nausea, dyspepsia, hypertension and uriniary tract infection.
Terrie Curran, president and chief executive officer at Phathom, commented: “This approval demonstrates Phathom’s commitment to changing the GI treatment landscape for patients and healthcare providers, bringing the first major innovation to the US Erosive GERD market in over 30 years. Erosive GERD can be extremely painful and often has a significant impact on patients. Research has shown patients and healthcare providers are largely unsatisfied with current treatments and we are excited about the approval of a first-in-class treatment option that has the potential to meet a large unmet medical need.”
The drug is expected to become available in the US in December 2023.
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