EC approval for Advicenne's ADV7103/Sibnayal

4 May 2021

The European Commission (EC) has granted marketing authorization to ADV7103 (potassium citrate/potassium hydrogen carbonate), proposed trade name Sibnayal, for the treatment of distal renal tubular acidosis (dRTA), says French biotech Advicenne (Euronext: ADVIC).

This approval makes ADV7103 the first and only label-approved drug for the treatment of dRTA in adults, adolescents and children aged one year and older. With the approval, Advicenne has the opportunity to make a significant difference to patients suffering from dRTA, classified as an orphan condition affecting no more than 1 to 2 individuals per 10,000 people in Europe.

The EC marketing authorization will be valid in all European Union member states, as well as in the European Economic Area (EEA) countries (Iceland, Liechtenstein and Norway).

Management changes as recently-appointed CEO quits

Advicenne also yesterday announced several changes in governance and in its senior leadership team.

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