ADV 7103 filed with EMA for distal renal tubular acidosis.- Advicenne

Advicenne announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead drug candidate, ADV 7103, as a treatment for distal renal tubular acidosis (dRTA). The application comes after positive results in a pivotal Phase III clinical trial (B21CS) and its twenty-four-month extension study (B22CS). In view of patient numbers and the absence of approved treatments for dRTA, ADV 7103 had previously received orphan medicinal product designation in Europe in 2017. Marketing authorization for ADV 7103 is anticipated in mid-2020.

Comment: The commercial launch of ADV 7103 in Europe is anticipated for late-2020. In North America, ADV 7103 has received clearance from the US Food and Drug Administration and Health Canada for a pivotal Phase III clinical trial for the treatment of dRTA patients. Commercial launch in the United States is anticipated for 2021. In addition to dRTA, ADV 7103 is currently in Phase III clinical studies for a second indication, cystinuria, an inherited renal tubulopathy.