FDA accepts application for faricimab for wet AMD, DME
The FDA has accepted Genentech’s biologics license application under priority review for faricimab to treat neovascular age-related macular degeneration and diabetic macular edema.
The submission was also accepted for diabetic retinopathy, and the European Medicines Agency validated the marketing authorization application for the drug for wet AMD and DME.
“If approved, faricimab would be the first in a new class of eye medicines targeting two key pathways that drive retinal disorders, with the potential to offer durable vision outcomes with fewer eye injections than the current standard of care,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a press release. “Therefore, we hope faricimab will become a new treatment option for millions of people living with wet AMD and DME.”
The submission was based on results from four phase 3 studies that showed that faricimab, given at intervals up to 4 months, conferred noninferior vision gains compared with aflibercept administered every 2 months. Approximately 50% of patients who received faricimab were able to extend their treatment time to every 4 months. Faricimab was well tolerated, and no new or unexpected safety signals were identified.
Long-term extension studies in wet AMD and DME are underway, as are trials of faricimab’s efficacy and safety in patients with macular edema secondary to central and branch retinal vein occlusion.