JW Pharmaceutical gout drug shows superiority in phase 3 trial

SEOUL - JW Pharmaceutical revealed that its gout medication, Epaminurad, outperformed Febuxostat 40mg in a multinational Phase 3 trial. The study involved 612 patients across five countries. Epaminurad was tested at 6mg and 9mg doses, compared to Febuxostat. Primary efficacy was measured by the percentage of patients with serum uric acid below 6 mg/dL in the final three readings.

Epaminurad 6mg group achieved a 50.0% response rate (76 out of 152 patients), while Febuxostat 40mg group had a 38.3% response rate (59 out of 154 patients). The difference in response rate was 12.0 percentage points with a 95% confidence interval of 1.26 to 22.6, indicating statistical superiority. There was no significant difference in adverse events between the two groups.

However, the 9mg dose group did not meet non-inferiority criteria compared to Febuxostat 80mg. JW Pharmaceutical will review efficacy in specific patient populations and consider approval strategies for the higher dose. The company aims to file a New Drug Application for regulatory approval in South Korea in 2027. The drug was chosen for South Korea's Ministry of Food and Drug Safety's New Drug Approval and Evaluation Innovation Plan pilot project.