Advicenne secures permanent UK approval for Sibnayal
French rare disease specialist Advicenne (ALDVI: PA) has secured unlimited renewal of the UK marketing authorization for Sibnayal (potassium citrate/potassium bicarbonate), marking another regulatory milestone for its lead kidney disease therapy as the company also awaits a key US approval decision later this year.
The Medicines and Healthcare products Regulatory Agency (MHRA) granted the unlimited renewal effective from June 2026, following the mandatory review conducted five years after the medicine's initial authorization. The decision makes Sibnayal's marketing authorization permanent in the UK and follows a similar renewal in the European Union.
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