FDA Approves VOQUEZNA® (vonoprazan) Tablets for Erosive GERD Treatment
The FDA's approval of VOQUEZNA® (vonoprazan) tablets introduces a novel potassium-competitive acid blocker (PCAB) for adults suffering from Erosive Esophagitis, also known as Erosive GERD. This approval is based on the positive outcomes from the Phase 3 PHALCON-EE study, which demonstrated VOQUEZNA's efficacy in healing and maintaining the healing of Erosive GERD, as well as providing relief from associated heartburn symptoms.
Key Highlights:
- VOQUEZNA 20 mg showed a healing rate of 93% by Week 8, compared to 85% for lansoprazole 30 mg.
- Superior healing rates were observed in patients with moderate-to-severe disease at Week 2.
- VOQUEZNA 10 mg was superior in maintaining healing at six months compared to lansoprazole 15 mg.
Adverse Events: The most common adverse events during the healing phase included gastritis, diarrhea, abdominal distension, abdominal pain, and nausea. In the maintenance phase, common adverse events were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
Significance: This approval represents a significant advancement in the treatment of Erosive GERD, offering a new therapeutic option for patients and healthcare providers. VOQUEZNA is expected to be available in the U.S. by December 2023.
About Erosive GERD: Erosive GERD affects approximately 20 million people in the U.S., characterized by erosions in the gastric mucosa due to acidic reflux. Without adequate treatment, it can lead to more severe conditions, including Barrett’s esophagus and esophageal cancer.
About Phathom Pharmaceuticals: Phathom Pharmaceuticals is dedicated to developing and commercializing novel treatments for gastrointestinal diseases. The company has exclusive rights to vonoprazan in the U.S., Europe, and Canada.
Important Safety Information: Patients are advised to consult their healthcare provider for a comprehensive list of potential side effects and important safety information before starting treatment with VOQUEZNA.