The CHMP recommendation will now be forwarded to the European Commission for final marketing approval, which typically occurs within 60 to 90 days. Once the product receives its marketing authorization and its price is agreed, Febuxostat will be marketed by Ipsen in France under the brand name Adenuric. Outside France, the commercialization of the product will be partnered. Adenuric is to be indicated for the treatment of chronic hyperuricaemia for conditions in which urate deposition has already occurred.
Jean-Luc Belingard, chairman and CEO of Ipsen, said: “This innovative drug pioneers the first major treatment of gout for more than 40 years.”