Novartis announced that the U.S. Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. Seeking to make brolucizumab available as quickly as possible, Novartis 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 U.S. will be living with wet AMD, a leading cause of blindness worldwide and a rapidly growing public health concern1. 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 blindness2.
“Reaching this milestone is an important step in our efforts to reimagine the treatment journey for people with wet AMD and their caregivers,” said Fabrice Chouraqui, President, Novartis Pharmaceuticals Corporation. “We are looking forward to the potential of a new option for patients with wet AMD, who often have to navigate considerable physical and emotional difficulties caused by deteriorating vision.”
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