FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Grants Priority Review to Novartis’ AMD Treatment

April 23, 2019

FDA granted priority review to Novartis’ treatment for macular degeneration, brolucizumab (RTH258).

The drug is a treatment for wet, age-related macular degeneration, which is expected to effect up to 1.75 million Americans next year. Left untreated, the condition can cause blindness.

The FDA granted the rapid review based on positive results from two Phase III trials that measured brolucizumab against Regeneron’s aflibercept. The trials also met their secondary endpoints, which found that “significantly fewer” patients in the brolucizumab group showed disease activity compared with patients in the aflibercept group.

If approved by the FDA, brolucizumab could be on the market by the end of this year, Novartis said.

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