Advicenne Withdraws ADV7103 New Drug Application in the USA for Distal Renal Tubular Acidosis
核心洞察
Advicenne has voluntarily withdrawn its New Drug Application (NDA) for ADV7103 in the treatment of primary distal Renal Tubular Acidosis (搜索) (dRTA) in the USA.
The withdrawal follows recognition that additional Chemistry, Manufacturing and Controls (CMC)-related work cannot be completed within the current FDA review cycle.
ADV7103 (Sibnayal®), approved in 2021, remains marketed in the European Union, the United Kingdom, Saudi Arabia, and the United Arab Emirates.
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, has announced the voluntary withdrawal of its New Drug Application (NDA) for ADV7103 in the treatment of primary distal Renal Tubular Acidosis (搜索) (dRTA) in the USA.
During the review process and ongoing communications between Advicenne and the U.S. Food and Drug Administration (搜索) (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.
Regulatory Status of ADV7103
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 the United Arab Emirates (UAE). The company notes that Sibnayal® is marketed in more than 25 countries in Europe.
The withdrawal of the U.S. NDA represents a setback for the company's regulatory program in the United States, where a decision had previously been anticipated. The CMC-related work identified during the FDA review could not be completed within the current review cycle, prompting the voluntary withdrawal.
Company Response and Next Steps
The Company is hosting a webinar for shareholders, in French, on Tuesday September 1st, 2026 at 6:00PM. The webcast will be recorded and posted on Advicenne's website.
Advicenne is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal® (ADV7103) has received Marketing Approval for distal renal tubular acidosis (搜索) in the EU, the UK, KSA and UAE. Headquartered in Paris, Advicenne has been listed on the Euronext Paris stock exchange since 2017, and has been listed on Euronext Growth Paris since its transfer on March 30, 2022.