Advicenne Advances in US with Positive FDA Reviews for ADV7103

Advicenne, a pharmaceutical company specializing in rare kidney diseases, announces key advances for its drug ADV7103 in the United States. The FDA has authorized the filing of a marketing authorization application for ADV7103 in dRTA without requiring additional clinical studies. This decision is based on European data deemed sufficient.

The FDA also approved ADV7103's orphan designation in cystinuria, allowing for constructive discussions for its clinical development. The company plans to file an MAA in 2025, facilitated by the orphan drug designation.

These successes should accelerate partnerships for the commercialization of ADV7103 in the United States, with the receipt of a first proposal, the details of which remain confidential.