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www.fdanews.com/articles/80729-genentech-will-file-for-fda-approval-of-lucentis

GENENTECH WILL FILE FOR FDA APPROVAL OF LUCENTIS

September 7, 2005

Genentech will file a complete biologics license application for the investigational drug lucentis in December. In addition, the company announced that it is in discussion with the FDA regarding plans to initiate a Phase IIIb clinical study of lucentis for patients with wet age-related macular degeneration (AMD).

The study is anticipated to begin before the end of 2005. It is being designed to evaluate the safety of two different doses (0.3 mg and 0.5 mg) of lucentis in a broad wet AMD population. Patients will receive lucentis once a month for three months with criteria-based re-treatment options. Genentech anticipates that patients with wet AMD who have not received prior treatment for their disease or who continue to have active disease despite treatment with FDA-approved therapies may be eligible to enroll in the study.

The study will be conducted at more than 100 sites in the U.S. and will enroll approximately 5,000 patients.