Advicenne Prepares For Launch As Rare Kidney Disease Drug Is Filed In The EU
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.
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Advicenne should soon find out whether the European Medicines Agency will give its product, ADV7103, the thumbs up. Approval then wouldn’t be far off.
With EU approvals in the bag for Ozalin, a novel oral midazolam solution for use in children, Switzerland-based Primex outlines plans for launch in Europe, and US development.
Looking to raise up to €39.7m through a stock market listing, French firm Advicenne has been developing ADV7103, which could soon become the first drug to be approved for distal renal tubular acidosis.