FDA to Lilly ICOS: 'NO RUSH' on
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Seattle, April 30, 2002 --- Lilly ICOS LLC announced today that the company received an 'approvable letter' for the drug Cialis (tadalafil, IC351) from the U.S. FDA. The impotency drug Cialis is a phosphodiesterase (PDE-5) inhibitor, distinguished from Viagra by a long duration of action and great selectivity, According to the company press release, which was posted to both the ICOS and the Eli Lilly websites, FDA approval was contingent upon "...successful completion of additional clinical pharmacology studies, labeling discussions, and manufacturing inspections."
Cialis
has shown in clinical trials that it works faster and lasts far longer
than Viagra. But because the medicine stays in the body longer, the FDA
may want Lilly and ICOS to investigate the lingering effects of the drug
to see if any safety risks arise. Lilly officials in a conference call
with analysts declined to describe the nature of the new Cialis clinical
trials, but called them "confirmatory'' studies. One Lilly executive
said the U.S. Food and Drug Administration was concerned with the potential
for recreational use or abuse of erectile dysfunction drugs.
FDA
Approval of Cialis now appears to be pushed back approximately one year,
well into 2003, the delay being widely interpreted as a disappointment
to Lilly ICOS, which had hoped to launch the product in mid-2002. Speaker-training
seminars for physician experts, originally planned to coincide with a
product launch and scheduled for early May, were postponed indefinitely.
Lilly
ICOS is a joint venture between the pharmaceutical giant Eli Lilly Co.
of Indianapolis, IN and the biotech start-up firm ICOS of Seattle, WA.
CEO of ICOS is George Rathman, who was a founder of Amgen, and the board
includes William H. Gates of Microsoft , who is also a major investor
in the company.
Abstracts of peer-reviewed publications: