(AOF) – Advicenne has announced that ADV7103, its proprietary drug in phase III in the United States, has been granted orphan drug status for the treatment of distal renal tubular acidosis (dRTA). This designation was issued by the Food and Drug Administration. This drug is an innovative and proprietary combination of two active pharmaceutical ingredients (potassium citrate and potassium bicarbonate) in the form of coated, sustained-release granules.
The specific formulation of ADV7103 aims to optimize the daily administration of the active ingredients and thus improve the compliance and quality of life of patients with dRTA.
dRTA results in a drop in blood pH causing many complications such as growth retardation, rickets (bone development disease in children), lithiasis, nephrocalcinosis and, in some cases, hearing loss. This disease can eventually lead to chronic renal failure.
In the United States, dRTA, in its genetic and secondary forms, affects between 20,000 and 30,000 patients. In Europe, the number of patients is estimated between 30,000 and 50,000 patients.
With a view to creating additional value, Advicenne is studying the possibility of filing an application for orphan designation in the cystinuria indication in the United States.
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Loss of speed in European research
European research is losing ground to American and Chinese research. In twenty years, Europe’s share has fallen from 41% to 31% in global R&D. China’s share jumped from 1% to 8%. As for the United States, which supplanted Europe, in 2001 it devoted only 2 billion euros per year more than Europe to R&D, whereas now this gap has reached 25 billion! Some experts accuse the European authorities of not having deployed effective policies. The financing of pharmaceutical research should therefore have been better targeted via the “Horizon 2020” programme. France only comes in eighteenth position in European funding despite the quality of its research. Conversely, the United States concentrates funding on Boston and a few centers of excellence.