Novartis announced that the FDA has accepted the company’s biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD). 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.
A priority review designation means FDA’s goal is to take action on an application within 6 months, compared to 10 months under standard review.
The regulatory application is primarily based on phase 3 data from the HAWK and HARRIER trials—prospective, randomized, double-masked multicenter studies. The primary endpoint of these studies was noninferiority 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 (23.5% of brolucizumab 6 mg patients versus 33.5% of aflibercept patients in HAWK, and 21.9% versus 31.4%, respectively, in HARRIER (P=0.0022 for both) as well as retinal fluid—key markers used by physicians to help guide management of the disease in clinical practice (31% fewer patients on brolucizumab 6 mg had intra-retinal fluid (IRF) and/or sub-retinal fluid (SRF) in HAWK, and 26% fewer in HARRIER, versus aflibercept (P<0.0001 for both), according to Novartis.
“Reaching this milestone is an important step in our efforts to reimagine the treatment journey for people with wet AMD and their caregivers,” Fabrice Chouraqui, President, Novartis Pharmaceuticals, said in a company news 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.”