Advicenne Receives Positive CHMP Opinion Recommending Approval of ADV7103 (sibnayal) for the Treatment of Distal Renal Tubular Acidosis (dRTA)

Regulatory News:

Advicenne (Paris:ADVIC) (BSE:ADVIC) (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.

“The positive opinion issued by the CHMP for our lead medicine ADV7103 (Sibnayal) in dRTA demonstrates Advicenne’s unique expertise in clinical development and innovative formulations and continues our dedication to patients with this disease. While awaiting the decision of the European Commission, we are already preparing the commercialization of our medicine in Europe, which will be carried out through targeted partnerships to ensure rapid and broad market access. I also want to take this opportunity to thank all Advicenne colleagues, past and present, who have made this Sibnayal registration possible.” states Dr. André ULMANN, Advicenne’s Interim Chief Executive Officer.

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 ADV7103.

While the standard of care (SoC) medicine today requires three to six daily intakes including during night, ADV7103 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.

In order to make ADV7103 quickly and broadly available in all EU countries, Advicenne has decided to set up partnerships with specialized distributors. This approach will allow Advicenne to allocate its resources on the clinical development of ADV7103 in the United States and to develop its second indication for the medicine in cystinuria.

About dRTA
Distal renal tubular acidosis dRTA is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure.