Advicenne Announces the Unlimited Renewal of the Marketing Authorization for Sibnayal® in the United Kingdom
Regulatory News:
Advicenne S.A. (Euronext Growth Paris - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases, announces the unlimited renewal of the Marketing Authorization (MA) for Sibnayal® (a fixed-dose combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) in the United Kingdom.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted the unlimited renewal of MA for Sibnayal® effective June 2026. This renewal, which is mandatory five years after the initial grant, definitively validates the MA in the United Kingdom. Following the renewal of the marketing authorization in the European Union, the decision by the British authorities highlights the therapeutic profile of Sibnayal® in the treatment of dRTA, a serious renal conditions affecting children and adults.
Advicenne’s regulatory program is particularly robust, with several marketing authorizations obtained for Sibnayal® in the Gulf countries, the recent reimbursement approvals for Likozam® and Sibnayal® in the French market, as well as the review of the registration dossier for ADV7103 by the U.S. Food and Drug Administration and a decision expected on September 3, 2026.
