Advicenne Withdraws ADV7103 Marketing Authorization Application in the United States
The pharmaceutical company specializing in nephrology has terminated its American marketing authorization process for its treatment of primary distal renal tubular acidosis, due to additional work required in the field of manufacturing and quality control.
The medication remains authorized and commercialized in several markets outside the United States.
Advicenne (Euronext Growth Paris ALDVI - FR0013296746) announced on August 31, 2026 the voluntary withdrawal of the marketing authorization application for ADV7103 in the treatment of primary distal renal tubular acidosis in the United States.
According to the company, the review of the file and recent exchanges with the American Food and Drug Administration (FDA) highlighted the need for additional work in the CMC field (Chemistry, Manufacturing and Controls). This work cannot be completed within the timeframe of the ongoing evaluation.
A Medication Already Authorized in Several Markets
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ADV7103 (Sibnayal), authorized in 2021, is currently commercialized in the European Union and the United Kingdom. It is also approved in Saudi Arabia and the United Arab Emirates.
According to the company, the treatment is commercialized in more than 25 countries in Europe. Advicenne is organizing a videoconference in French on September 1, 2026 at 6:00 PM, which will be recorded and available on its website.
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