CHMP positive for Sibnayal for treatment of distal renal tubular acidosis. - Advicenne.

Advicenne 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 ADV 7103 (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. This CHMP positive opinion is based on results of a pivotal Phase III trial (B21CS) and its twenty-four month extension study (B22CS) conducted in adult and pediatric patients with dRTA demonstrating the clinically relevant therapeutic effect of ADV 7103. While the standard of care (SoC) medicine requires three to six daily intakes including during night, ADV 7103 treatment consists of only two doses per day and provides complete night-time coverage for patients. In addition, gastrointestinal tolerability was improved. Plasma potassium and urinary calcium was normalized.