Novartis has secured approval from the European Commission (EC) for its Beovu (brolucizumab) to treat wet age-related macular degeneration (AMD).
Beovu is claimed to be the first EC-approved anti-VEGF treatment to show better resolution of retinal fluid (IRF/SRF) against aflibercept.
Wet AMD, a chronic and degenerative eye disease, will be caused due to excess amount of VEGF protein that boosts the growth of abnormal blood vessels underneath the macula.
The EC approval allows to market Beovu in 27 European Union member states, in addition to the UK, Iceland, Norway and Liechtenstein.
Beovu, an advanced humanised single-chain antibody fragment (scFv), blocked activation of VEGF receptors through prevention of the ligand-receptor interaction in preclinical studies.
The regulator’s approval was based on data from the phase III HAWK and HARRIER clinical studies, in which Beovu achieved the primary endpoint.
HAWK and HARRIER are global head-to-head trials, which enrolled over 1,800 patients in around 400 centres across the world.
Part of the phase III clinical development of Beovu, the 96-week prospective, randomised and double-masked multi-centre studies have been framed to compare the efficacy and safety of intravitreal injections of brolucizumab 6mg HAWK and HARRIER) and 3mg (HAWK only) against aflibercept 2mg in patients with wet AMD.
In October 2019, the company secured approval from the US Food and Drug Administration for Beovu to treat wet AMD.
Last month, the firm also secured Swissmedic approval for Beovu in Switzerland, as well as Australian TGA approval to treat wet AMD. Additional regulatory filings are under review in Canada, Japan and Brazil.
Novartis Pharmaceuticals president Marie-France Tschudin said: “Currently, wet AMD patients, who are often older, can face significant challenges in managing their disease. We believe that Beovu, and its ability to resolve fluid, brings great therapeutic value that will help physicians optimize treatments for patients based on disease activity.
“With the approval of this innovative biologic, Novartis is continuing to reimagine medicine for people living with wet AMD.”
Last month, Novartis has secured approval for Mayzent (siponimod) in the European Union for the treatment of secondary progressive multiple sclerosis (SPMS) in adults.