Phanthom Pharmaceutical Receives the US FDA Approval for Vaquenza (vonoprazan) for the Treatment of Erosive GERD
Shots:
- The approval was based on a P-III (PHALCON-EE) study evaluating safety & efficacy of vonoprazan (10 mg) vs lansoprazole (30mg) in patients (n=1027) with erosive esophagitis
- The study met 1EP of complete healing by Week 8 with a 93% healing rate vs 85%. It demonstrated superior healing at Week 2 (70% vs. 53%). In the maintenance phase, voquezna surpassed lansoprazole (15mg) at 6 mos. for all patients (79% vs. 72%) & moderate-to-severe cases (75% vs. 61%)
- As a 2EP, it demonstrated non-inferiority in relieving heartburn over 6 mos. Vaquenza is an oral PCAB that inhibits stomach acid secretion. Vonoprazan, acquired by Phathom from Takeda, has demonstrated the potential to achieve crucial pH levels, enhancing its effectiveness
Ref: Phathom Pharmaceuticals | Image: Phathom Pharmaceuticals
Related News:- Phathom Reports P-III Study (PHALCON-NERD-301) Results of Vonoprazan for Symptomatic Non-Erosive Gastroesophageal Reflux Disease
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
