In an approvable letter to the company the FDA indicated that the agency required an additional study because it believed the results of the three trials conducted to date did not provide substantial evidence that the drug is effective. The agency went on to provide a number of comments on the results previously presented by Cellegy and recommendations concerning the design and protocol of the additional required study.
Cellegesic was the subject of an FDA not approvable letter in December 2004. An amended NDA, containing new analyses, was resubmitted to the FDA in April 2005, which resulted in a review by the FDA’s Cardio-Renal advisory committee in April 2006.
The advisory committee’s final vote was six members of the committee for “approval” of Cellegesic and six for “approvable pending another study of effectiveness.” There were no votes for “not approvable.” Cellegesic has been under review at the FDA since then.
“We believe that we achieved the requirements for Cellegesic to be approved. The FDA reached a different conclusion that the product was approvable, but requires another trial to demonstrate efficacy. We are carefully considering all of our options and will be scheduling a meeting with the FDA,” said Richard Williams, Cellegy’s chairman and interim CEO.