FDA Reviews Advicenne's Sibnayal® for U.S. Approval

Advicenne, a pharmaceutical company focused on innovative treatments for rare kidney diseases, announced that the FDA has accepted its New Drug Application for Sibnayal® in the United States. Sibnayal® is a fixed combination of potassium citrate and potassium bicarbonate for treating distal Renal Tubular Acidosis (dRTA). The FDA has set the target date for a final approval decision, known as the PDUFA date, for September 3, 2026.

Following the submission of the New Drug Application in November 2025, the FDA completed its 60-day filing review, during which Advicenne addressed several agency queries. The application includes European clinical studies aligned with the renewed Marketing Authorization dossier in Europe.