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Novartis Says FDA Accepts BLA For Brolucizumab

Novartis (NVS) said Monday that the US Food and Drug Administration accepted the company's Biologics License Application or BLA for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration or AMD, also known as neovascular AMD, or nAMD.

Novartis said it used a priority review voucher to expedite FDA review. If approved by the FDA, Novartis anticipates launching brolucizumab by the end of 2019.

Estimates suggest that by 2020, 1.5 to 1.75 million people in the US will be living with wet AMD, a leading cause of blindness worldwide and a rapidly growing public health concern.

As the disease progresses, patients may experience loss of central vision, resulting in an inability to complete daily tasks. Without treatment, vision can rapidly deteriorate and may lead to blindness, Novartis said.

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