Posted by Michael Wonder on 13 Mar 2019
Advicenne announces submission of European marketing authorisation application for ADV7103 as treatment for distal renal tubular acidosis
12 March 2019 - Advicenne announces today that it has submitted a marketing authorisation application to tEMA for its lead drug candidate, ADV7103, as a treatment for distal renal tubular acidosis.
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, ADV7103 had previously received orphan medicinal product designation in Europe in 2017.
Marketing authorisation for ADV7103 is anticipated in mid-2020. This schedule is in keeping with the late-2020 commercial launch strategy announced by Advicenne at its IPO: directly in the five principal European markets (France, Germany, Italy, Spain, United Kingdom) and through partnerships in other European Union countries.
