No Cialis committee?
Executive Summary
Lilly/ICOS's erectile dysfunction therapy Cialis is not scheduled for review at May advisory committee that will discuss Levitra's QT prolongation issues. Lilly says there has been no evidence of QT problems with Cialis, even in study patients dosed with up to 500 mg; the maximum dose being sought for approval is 20 mg. Like Levitra, Cialis is "approvable" at FDA and was recently approved in Europe. EMEA notes no cardiovascular effects were observed, but Lilly/ICOS "has committed to conduct a HERG channel assay with tadalafil as a post-authorization follow-up measure"...