Advicenne: MHRA Indefinitely Renews Sibnayal Marketing Authorization in the UK
On Wednesday, pharmaceutical company Advicenne announced the indefinite renewal of the marketing authorization (MA) for Sibnayal in the United Kingdom, a decision made by the British regulator MHRA in June 2026. This renewal, mandatory five years after the initial grant, strengthens the regulatory positioning of the laboratory in the treatment of distal renal tubular acidosis.
An Indefinite Regulatory Renewal
The British Medicines and Healthcare products Regulatory Agency (MHRA) has granted an indefinite extension of the MA for Sibnayal, a fixed-dose combination of potassium citrate and potassium bicarbonate intended for the treatment of distal renal tubular acidosis (dRTA). This renewal, occurring in June 2026, definitively validates the commercial authorization in the United Kingdom following that of the European Union. Sibnayal thus enjoys regulatory recognition in these two major markets for this rare renal pathology.
Expansion of the Regulatory Portfolio
Advicenne is expanding its regulatory development program: several marketing authorizations for Sibnayal have been obtained in the Gulf countries (Saudi Arabia and the United Arab Emirates), while Likozam and Sibnayal have recently received reimbursement approval in France. The laboratory continues the review of its authorization dossier for ADV7103 with the United States Food and Drug Administration, with a decision expected on September 3, 2026. ADV7103 is also in advanced development for the treatment of cystinuria in Europe and the United States.
