Novartis has announced the wet age-related macular degeneration treatment brolucizumab, which was backed by data from the HAWK and HARRIER trials, has received FDA approval.
The anti-VEGF treatment brolucizumab (Beovu) injection has been approved by the US Food and Drug Administration (FDA) for the treatment of wet age-related macular degeneration (wAMD)—becoming the first approved anti-VEGF to offer greater fluid resolution versus aflibercept and the ability to maintain eligible wAMD patients on a 3-month dosing interval.
Back with data from the phase 3 HAWK and HARRIER trials, a Biologics License Application was submitted for the treatment in April and it received a priority review designation from the FDA at the time of submission.
“The approval of Beovu delivers on the Novartis commitment to reimagining treatments for patients suffering from serious visual impairment,” said Marie-France Tschudin, president of Novartis Pharmaceuticals. “The product labels of existing treatments state that they are not as effective when dosed every 12 weeks. Beovu is the first to offer less frequent dosing in the first year of therapy while maintaining its effectiveness. This gives more time for wet AMD patients to focus on what’s important in their lives.”
The HAWK and HARRIER trials demonstrated non-inferiority versus aflibercept in mean change of best-corrected visual acuity at week 48. Investigators of both trials found approximately 30% of patients gained at least 15 letters at week 48. Brolucizumab demonstrated the ability to induced greater reductions in central subfield thickness.
Additionally, fewer patients on brolucizumab had intra-retinal and/or sub-retinal fluid. HAWK and HARRIER also demonstrated more than half of patients on brolucizumab(56% in HAWK, 51% in HARRIER) were able to maintain a 3-month dosing interval.
A release from Novartis noted brolucizumab exhibited an overall safety profile comparable to aflibercept. The release also notes brolucizumab is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or with known hypersensitivity to brolucizumab.
The release did not state when Novartis expects brolucizumab to be made available.
For more information on the clinical usage of brolucizumab, check out our interview with Carl Regillo, MD, director of retina service at Wills Eye Hospital and professor of ophthalmology at Thomas Jefferson University, who presented 96-week data from HAWK and HARRIER studies at ASRS 2019.