The FDA has accepted a biologics license application for brolucizumab for the treatment of neovascular age-related macular degeneration, Novartis announced in a press release.
The application was based on phase 3 data from the HAWK and HARRIER trials, which found brolucizumab to be noninferior to aflibercept in mean change in best corrected visual acuity from baseline to week 48.
In addition, significantly fewer patients treated with brolucizumab had disease activity and retinal fluid compared with patients treated with aflibercept.
“Reaching this milestone is an important step in our efforts to reimagine the treatment journey for people with wet AMD and their caregivers,” Novartis Pharmaceuticals President Fabrice Chouraqui said in the release. “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.”
Novartis used a priority review voucher to expedite FDA review and anticipates launching brolucizumab, if approved by the FDA, by the end of this year, the release said.