Alcon updates filing status of RETAANE® new drug application

Alcon, Inc. has announced that it has filed the second portion of its “rolling” New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for RETAANE® 15mg (anecortave acetate for depot suspension), an investigational treatment for preserving the vision of patients with all forms of wet age-related macular degeneration (AMD).

The announcement was made today during a meeting of international retinal experts in Amsterdam, Holland.

RETAANE® depot is a fast track designated product that was also accepted into FDA’s new Pilot 1 Continuous Marketing Application (CMA) program because of its potential as a treatment for a significant unmet medical need in patients with a serious condition. The “rolling” NDA permitted under this new FDA program allows designated NDAs to be submitted in specified reviewable units as each is completed, rather than as one package when the last unit is completed. The three main reviewable units are the Chemistry, Manufacturing and Controls (CMC) unit; the Pre-Clinical unit; and the Clinical unit. The fast-track designation provides a performance target for the FDA to complete its review of each unit within six months of its submission.

The FDA has completed its initial review of the RETAANE® depot CMC reviewable unit, which was filed in 2003. Furthermore, the pre-approval inspection of Alcon’s manufacturing facility has been completed with no negative findings (no 483 observations). Alcon also submitted the Pre-Clinical unit for RETAANE® depot in March of this year, and has responded to all questions to date.

Alcon plans to complete the submission of the RETAANE® depot NDA with the filing of the Clinical unit in the fourth quarter of 2004. This unit will incorporate the twelve-month results from the on-going, multi-center, phase III clinical trial comparing RETAANE® depot with photodynamic therapy (PDT) in 530 patients with wet AMD, along with results from other clinical studies completed during the development program. If approved, consistent with the spirit of the CMA Pilot, Alcon is prepared to quickly make RETAANE® depot available for treating wet AMD.

“By piloting new review programs such as the Continuous Marketing Application program, the FDA is taking significant steps to ensure that safe and effective treatments that address significant unmet medical needs are efficiently made available to the American public,” said Scott Krueger, Ph.D., Alcon’s Vice President of Regulatory Affairs. “In anticipation of the upcoming twelve-month clinical safety and efficacy data from our ongoing Phase III study, we are looking forward to submitting for FDA review the final NDA unit for RETAANE® depot. Once we have filed this last unit, we believe the drug development program for RETAANE® depot will have generated a compelling database that supports its use as a treatment for wet AMD.”


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