Novartis nabs FDA priority review for potential eye blockbuster

April 16, 2019

Novartis announced that the U.S. Food and Drug Administration have granted priority review status for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. If approved by the FDA, Novartis anticipates launching brolucizumab by the end of 2019.

If approved this will have Novartis' med go up against Roche’s Lucentis and Regeneron’s Eylea.

According to Novartis, 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.

The regulatory application is primarily based on Phase III data from the HAWK and HARRIER trials - prospective, randomized, double-masked multi-center studies. The primary endpoint of these studies was non-inferiority to aflibercept in mean change in best-corrected visual acuity (BCVA) from baseline to week 48 (mean change in BCVA of 6.6 letters for brolucizumab 6 mg versus 6.8 letters for aflibercept in HAWK and 6.9 letters versus 7.6 letters, respectively, in HARRIER). HAWK and HARRIER 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.

Additionally, at week 48 in the studies, key secondary endpoint assessments showed significantly fewer brolucizumab patients with disease activity.

Read the full Novartis release.