Advicenne (Euronext Growth Paris:ALDVI), a specialty pharmaceutical company focused on rare renal diseases, announced on Tuesday that it has secured key regulatory milestones for its ADV7103 drug in the United States.
The US Food and Drug Administration (FDA) has said that European clinical data can be used to support an application for registration in dTRA (Distal Renal Tubular Acidosis) without further clinical trials.
Additionally, the positive orphan drug designation in cystinuria has paved the way for productive discussions with the FDA on development in this indication.
These advancements are poised to bolster Advicenne's partnership prospects for commercialising ADV7103 in the US. The company has already garnered interest from potential partners in the region.
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