Vertex races to FDA after phase 3 kidney disease data impress analysts
Vertex reported phase 3 data showing povetacicept significantly reduced proteinuria compared to placebo in immunoglobulin A nephropathy and said it plans to seek FDA approval by the end of March.
The Week 36 interim analysis showed a 49.8% placebo-adjusted reduction in urine protein to creatinine ratio, meeting the trial’s primary endpoint, while analysts noted reductions in serum galactose deficient IgA1 and hematuria resolution that demonstrate broader clinical impact. Vertex said the drug was generally safe and well tolerated with no serious adverse events linked to the molecule and no deaths, and Citi analysts raised their probability of approval to 90% following the data.
The program’s rapid progression from late-stage data to a near-term FDA submission reflects the region’s strength in translating cutting-edge research into life-changing therapies.