(AOF) – Advicenne announces that its drug ADV7103 has obtained orphan drug designation (ODD) from the FDA for the treatment of cystinuria in the United States. The biotech specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases specifies that ADV7103 is one of the rare drugs to obtain orphan designation in the United States in two indications, cystinuria and Acidosis. Distal Renal Tubular (ATRd).
Managing Director Didier Laurens says he is “very proud” of the fact that “the first clinical data obtained in France have convinced the FDA of the benefit of ADV7103 in the treatment of cystinuria”. “The treatment of this condition with simplified alkalinization is a significant unmet medical need and constitutes a very significant potential market with more than 30,000 patients in the United States,” he emphasizes. “Obtaining this designation in cystinuria is the powerful lever we have been waiting for to accelerate and finalize discussions with potential partners in the United States.”
AOF – LEARN MORE
Learn more about the Pharmacy sector
Oncology, priority of pharmaceutical giants
Sanofi’s stock market disappointment recorded at the end of October 2023 underlines the new direction for the group, which has now set oncology as its number 1 priority. Efforts in this segment, where therapies are advancing the fastest, notably involve investments in R&D which weigh on profitability. Sanofi therefore announced a drop in its earnings per share in 2024 and the abandonment of its objective of an operating margin of 32% in 2025. Merck has just unveiled a new alliance. It will pay up to $22 billion to the Japanese group Daiichi Sankyo as part of a partnership on experimental cancer treatments. While some experts estimate that the United States represents nearly half of global oncology spending (drugs and treatments), or $196 billion in 2022, Chinese spending in this area has more than doubled in five years, going from 5 to 11.8 billion dollars.