Advicenne: FDA-approved marketing application for Sibnayal®

Advicenne announced that the FDA has agreed to review its application for marketing authorization for Sibnayal® in the United States. This treatment targets distal renal tubular acidosis (dRTA). The target date for the final decision, according to the Prescription Drug User Fee Act (PDUFA), is September 3, 2026.

After the application was submitted on November 2, 2025, the FDA confirmed its admissibility within 60 days. The FDA's acceptance is seen as recognition of Advicenne's work and the European clinical studies included in the application.

Didier Laurens, CEO of Advicenne, emphasizes the commitment to responding to FDA requests during the evaluation, aiming to offer this unique treatment to patients suffering from ATRd.