EU filing for once-daily dosing of Cialis

Lilly ICOS, the joint venture between US firms Eli Lilly and ICOS Corp, has submitted a regulatory filing for marketing approval to the European Medicines Agency (EMEA) for Cialis (tadalafil) 2.5mg and 5mg once-a-day dosing to treat erectile dysfunction. Lilly ICOS plans to file in the USA and Canada later in 2006. If approved, the first launches could occur in late 2007.

"We are very excited about the prospect of bringing Cialis Once-A-Day to the market in North America and Europe," stated Paul Clark, ICOS' chief executive. "Market research revealed that once-a-day therapy could especially appeal to an important segment of the patient population - the man in his 40s or 50s who takes a PDE5 inhibitor more frequently than average," he said, adding: "importantly, growth in worldwide Cialis sales, including Cialis Once-A-Day beginning in 2008 if approved, are expected to drive accelerated earnings for ICOS Corp."

The recent EMEA filing followed the completion of three Phase III clinical studies that evaluated the efficacy and safety of Cialis when administered once-a-day for the treatment of ED. Men with ED taking Cialis 5mg Once-A-Day experienced significantly improved erectile function compared to those taking placebo. Cialis 5mg Once-A-Day was generally well-tolerated with most frequently occurring side effects being upset stomach and headache.