FDA Accepts Application for Genentech’s Faricimab for the Treatment of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME)
ROCHE HOLDING LTD S/ADR (RHHBY)
NASDAQ:AMEX Investor Relations:
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Source: Business Wire
– Across four Phase III studies, approximately half of patients receiving faricimab could extend treatment time to every four months – the first time this level of durability has been achieved in Phase III wet AMD and DME studies –– If approved, faricimab would be the first and only medicine designed to target two distinct pathways that drive retinal diseases that can cause vision loss –– The European Medicines Agency has also validated the faricimab Marketing Authorization Application submission in wet AMD and DME – SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.F
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