Novartis has announced the US Food and Drug Administration (FDA) filing acceptance and priority review of its wet AMD drug, RTH258 (brolucizumab).
The governing body accepted the company's Biologics License Application, meaning that Novartis is now seeking to make the treatment available as quickly as possible for patients with wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD.
The decision is primarily based on Phase III data from the HAWK and HARRIER trials, which found that the drug was not inferior to Eylea (aflibercept) in mean change in best-corrected visual acuity. The mean change over 48 weeks was found to be 6.6 letters for RTH258 6 mg versus 6.8 letters for Eylea in HAWK and 6.9 letters versus 7.6 letters, respectively, in HARRIER.
The trials are the first and only global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy at week 48 starting with a 12-week dosing regimen.
"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."
If approved by the FDA, Novartis anticipates the launch by the end of 2019.
nAMD is the leading cause of severe vision loss and legal blindness in people over the age of 65 in North America, Europe, Australia and Asia, impacting an estimated 20 to 25 million people worldwide.