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Advicenne Withdraws US Application for Distal Renal Tubular Acidosis Drug

MT Newswires·08/31/2026 01:20:43
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01:20 AM EDT, 08/31/2026 (MT Newswires) -- Advicenne (ALDVI.PA) said Monday it withdrew the new drug application for its treatment for primary distal renal tubular acidosis, ADV7103, or Sibnayal, in the US. The application was withdrawn after the pharmaceutical company's discussions with the US Food and Drug Administration identified additional chemistry, manufacturing and controls-related work that could not be completed within the current review cycle. Sibnayal is approved in the United Arab Emirates and Saudi Arabia, and is currently marketed in the European Union and the UK.