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Advicenne Prepares For Launch As Rare Kidney Disease Drug Is Filed In The EU

 
• By Kevin Grogan

Having had a bid for accelerated assessment rejected by the EMA last year, the French biotech is getting a standard review for ADV7103 in dRTA patients and hopes to launch late 2020.

Advicenne finishes filing for rare kidney disease drug • Source: Shutterstock

Advicenne SA has finally submitted a marketing authorization application to the European Medicines Agency for its lead candidate, ADV7103, and commercial plans are well under way for what could be the first therapy approved for distal renal tubular acidosis (dRTA), a rare kidney disease.

The French company had originally hoped to get accelerated assessment from the EMA for the drug but last October, the agency's evaluation committee, the CHMP, rejected that request

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