Advicenne receives positive CHMP opinion recommending approval of ADV7103 (Sibnayal®) for the treatment of distal renal tubular acidosis (dRTA)
December 10, 2020
Paris, France, December 10, 2020 (6.00 pm CET) – Advicenne (Euronext: ADVIC) today announces the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of its lead product ADV7103 (Sibnayal®) as therapy for distal renal tubular acidosis (dRTA). The European Commission (EC) will now review the CHMP recommendation and a final decision on the Marketing Authorisation of ADV7103 in the European Union is expected in the coming weeks/months.