Advicenne decides to withdraw its ADV7103 New Drug Application in the USA

Advicenne decides to withdraw its ADV7103 New Drug Application in the USA

Regulatory News:

Advicenne (Euronext Growth Paris - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases, announces today the voluntary withdrawal of the New Drug Application (NDA) for ADV7103 in the treatment of primary distal Renal Tubular Acidosis (dRTA) in the USA.

During the review process and ongoing communications between Advicenne and the U.S. Food and Drug Administration (FDA), it was recognized that additional Chemistry, Manufacturing and Controls (CMC)-related work will need to be implemented, which cannot be completed within the current review cycle.

ADV7103 (Sibnayal®), approved in 2021, is currently marketed in the European Union and the United Kingdom. It is also approved in the Kingdom of Saudi Arabia (KSA) and United Arab Emirates (UAE).