Advicenne (Euronext Growth Paris:ALDVI), a specialty pharmaceutical company focused on rare kidney diseases, announced on Monday that the US Food and Drug Administration (FDA) has accepted for review its New Drug Application 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 (PDUFA) of 3 September 2026.
Advicenne submitted the NDA on 2 November 2025, and the FDA completed its standard 60-day filing review, during which the company addressed questions raised by the agency. The 505(b)(2) application incorporates European clinical studies that supported the recently renewed Marketing Authorization dossier in Europe.
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