US approves Phathom's Voquezna for erosive GERD
01 Nov 2023
Phase 3Clinical ResultDrug Approval
Phathom Pharmaceuticals said Wednesday that the FDA approved its potassium-competitive acid blocker Voquezna (vonoprazan) as a new treatment for adults with erosive gastroesophageal reflux disease (GERD) and heartburn associated with the condition. According to CEO Terrie Curran, the FDA nod brings "the first major innovation to the US erosive GERD market in over 30 years."
The resubmitted filing was supported by data from the Phase III PHALCON-EE study, which randomised 1024 patients to receive either Voquezna or the proton pump inhibitor lansoprazole in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.
Results showed that Voquezna achieved the 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. It also showed superior rates of healing in a secondary endpoint in patients with moderate-to-severe disease at week 2, compared to lansoprazole. In addition, Voquezna demonstrated non-inferiority to lansoprazole in the mean percentage of 24-hour heartburn free days over the healing period.
During the maintenance portion of the trial, the drug was found to be superior to lansoprazole overall in maintaining healing at 6 months in 79% of patients, versus 72% for lansoprazole. In a subset of patients with moderate-to-severe erosive GERD, the rates were 75% and 61%, respectively.
Prior FDA rejection
Phathom received a complete response letter from the FDA earlier this year relating to specifications and controls for a nitrosamine drug substance impurity. The company has said it implemented mitigation measures, including a "minor" reformulation of the drug product tablet, to inhibit growth of the impurity, and that it conducted a stability programme to show that the measures were effective and supported the commercial shelf-life.
Earlier this week, Phathom said it obtained FDA approval of for the reformulation of vonoprazan tablets for both Voquezna Triple Pak (vonoprazan/amoxicillin/clarithromycin) and Voquezna Dual Pak (vonoprazan/amoxicillin),= for the treatment of Helicobacter pylori infection in adults.
In September, the company applied for US approval of the drug as a potential treatment of non-erosive GERD based on Phase III results from the PHALCON-NERD-301 study. A decision there is expected in the third quarter of 2024.
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