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Genentech plans FDA application for wet AMD drug Lucentis
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Genentech Inc. plans to file an application with the Food and Drug Administration for its investigational drug ranibizumab in December, the company announced in a press release.
The FDA recently notified Genentech that it had denied the company’s request for fast-track designation of Lucentis (ranibizumab, Genentech), for the treatment of wet age-related macular degeneration, according to the press release. The denial will not affect the company’s timing in filing the complete biologic license application this year or the possibility of obtaining priority review for the drug, company officials said.
“We recognize the significant unmet medical needs of those with wet AMD and hope to make Lucentis available to patients by seeking FDA approval as quickly as possible,” Hal Barron, MD, Genentech’s senior vice president of development and chief medical officer, stated in the release.
Phase 3 data presented at the American Society of Retina Specialists meeting in July showed that treatment with the drug has improved vision in patients with wet AMD, according to the press release.
Genentech also announced that it is in discussion with the FDA about plans this year to initiate a phase 3b clinical study of Lucentis for patients with wet AMD, the release states.
The phase 3b study would test the safety of two doses of Lucentis, 0.3 mg and 0.5 mg, in patients with wet AMD. The study will include about 5,000 patients at 100 sites in the United States, according to the press release.
Lucentis is a humanized therapeutic antibody fragment designed to prevent new blood vessel growth and leakiness, which lead to wet AMD progression and vision loss, the press release said.