Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly and Company, announced that the European Committee for Proprietary Medicinal Products (CPMP) has issued a positive opinion for Cialis (tadalafil), an investigational oral PDE5 inhibitor for the treatment of erectile dysfunction. The CPMP has recommended to the European Commission that approval should be granted.
"We are extremely pleased by the CPMP's recommendation for approval of Cialis in Europe," said Richard Pilnik, president of European operations for Lilly. "This positive action by the CPMP brings Cialis one step closer to approval and launch in the European Union, and will soon help bring a new therapy to millions of men who suffer from ED."
"Based on its clinical profile, we are confident in the value and potential for Cialis," said Paul Clark, ICOS chairman and chief executive officer. "ED is a significant problem. In Europe alone, an estimated 31 million men suffer from the condition."
The CPMP, comprised of regulators from the European Union countries, based its positive opinion on its review of the comprehensive data package of Cialis. The submission was comprised of more than 60 studies in more than 4,000 humans to characterize the safety and efficacy profile of Cialis.
Following the CPMP's positive opinion, the application will be reviewed by the European Commission, which has authority to grant marketing authorization for the European Union. This authorization is anticipated for later this year.
Erectile Dysfunction is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. ED affects an estimated 152 million men and their partners worldwide. Up to 80 percent of ED cases are caused by physiological conditions, including cardiovascular disease and diabetes, with psychological factors accounting for the remaining 20 percent. In many cases, however, both psychological and physical factors contribute to the condition.