Ipsen's Adenuric gets nod from CHMP

French drugmaker Ipsen says that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has given a positive opinion for Adenuric (febuxostat) 80mg and 120mg tablets for the treatment of chronic hyperuricaemia in gout, and recommended it for marketing authorization. Final approval from the European Commission typically occurs within 60 to 90 days. Following clearance, Adenuric will become, since 1964, the first significant treatment alternative for chronic hyperuricaemia available to gout patients.

Adenuric is to be indicated for chronic hyperuricemia for conditions in which urate deposition has already occurred. The detailed recommendations for the use of this product will be described in the Summary of Product Characteristics, to be made available after the medication receives marketing authorization from the European Commission.

Domestic marketing of the drug will be conducted by Ipsen, and foreign sales will be partnered. Company chief executive Jean-Luc Belingard said: "we are very proud to receive this positive opinion for Adenuric from the EMEA, and look forward to bringing this new molecule to market, pending European Commission approval. This innovative drug pioneers the first major treatment of gout for more than 40 years."