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Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal) and announces Leadership Changes to support Commercialisation Regulatory News: Advicenne (Euronext: ADVIC) (Paris:ADVIC) (BSE:ADVIC), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases, is pleased to announce that the European Commission (EC) has granted marketing authorisation to ADV7103 (Sibnayal), for the treatment of distal renal tubular acidosis (dRTA). 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.
Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal) and announces Leadership Changes to support Commercialisation finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.
Advicenne Reports its Full-Year Financial Results to December 31, 2020 and Confirms its 2021 Outlook
Regulatory News:
Advicenne (Paris:ADVIC) (BSE:ADVIC) (Euronext: ADVIC), a French company specialized in the development of therapeutic products adapted to children and adults for treating nephrological and neurological orphan diseases, today reported its 2020 financial results.
2020 HIGHLIGHTS
Scientific developments
On March 10, 2020, Advicenne was authorized to make ADV7103 available within the framework of a Temporary Authorization for Use (TAU) scheme established by France s National Agency of Medicine and Health Products Safety (
Agence nationale de sécurité du médicament et des produits de santé (ANSM)). This authorization allows the exceptional use of coated 8 mEq and 24 mEq granules in sachets for the treatment of distal renal tubular acidosis (dRTA) in France. Its prescription is reserved for physicians specializing in nephrology.
Advicenne Expects Imminent Marketing Authorization for ADV7103 (Sibnayal) for dRTA in Europe finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.