(tadalafil) (tadalafil)
Status:
Erectile dysfunction: Response Submitted in U.S; Marketed in Europe and Mexico
Erectile dysfunction (ED) affects as many as 70 million men in North America and Europe.
Cialis® (tadalafil) is an oral PDE5 inhibitor for the treatment of erectile dysfunction (ED). Cialis is being developed by Lilly ICOS LLC ("Lilly ICOS"), a joint venture between ICOS and Eli Lilly and Company ("Lilly"). In February 2003, Lilly ICOS announced that Cialis, was available for sale in pharmacies in several European countries and Australia. Cialis is now broadly available by prescription across Europe, Mexico, Australia, and New Zealand. Lilly ICOS has marketing rights to Cialis in Europe and North America, and Lilly has an exclusive license from Lilly ICOS to market Cialis for the treatment of erectile dysfunction in the rest of the world.
In late April 2002, Lilly ICOS received an approvable letter from the U.S. Food and Drug Administration (FDA) for Cialis for the treatment of erectile dysfunction. A U.S. regulatory decision for Cialis is anticipated in the late second half of 2003, with product launch anticipated to occur shortly after approval. An FDA approval is contingent upon the successful completion of additional pharmacology studies, labeling discussions and acceptable manufacturing.
More than 90 Phase 1, 2 and 3 clinical trials have been conducted with Cialis. Integrated Phase 3 data regarding treatment of ED with Cialis have been reported at medical and scientific meetings in the U.S. and Europe.