BRIEF—FDA accepts Advicenne’s Sibnayal filing for review

French nephrology specialist Advicenne has announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Sibnayal (ADV7103), a fixed combination of potassium citrate and potassium bicarbonate for the treatment of distal renal tubular acidosis (dRTA). 

The FDA has set a target action date under the Prescription Drug User Fee Act for September 3, 2026.

Following the submission of the NDA dossier on November 2 last year, the FDA completed its standard 60-day filing review. 

During this period, Advicenne satisfactorily addressed several questions raised by the agency.

Didier Laurens, chief executive of Advicenne, said: “This acceptance acknowledges the outstanding work accomplished by the entire Advicenne team, across clinical, regulatory, and CMC functions, both in France and the USA. 

“It attests to the quality of our submission, which, I would like to emphasize, was filed precisely on schedule. We are now entering the substantive review phase, which is expected to continue through September 2026. During this time, we will remain fully committed to responding promptly and effectively to all FDA requests. Our main goal is to bring to US patients, their families, and caregivers the only therapy specifically designed for the treatment of dRTA.”