Novartis receives EC Approval for Beovu, a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide - Seite 2

The EC approval was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu met the primary endpoint, demonstrating gains in best corrected visual acuity (BCVA) that were non-inferior to aflibercept at year one (week 48)^1,5. Vision gains at year one were maintained at year two^1,5.

In fluid-related secondary endpoints, Beovu outperformed aflibercept^1,5. Significantly fewer patients had intra-retinal and/or sub-retinal fluid (IRF/SRF), two fluids which may disrupt the normal retinal structure and cause damage to the macula (31% for brolucizumab 6 mg vs. 45% for aflibercept in HAWK; 26% vs. 44%, respectively, in HARRIER at year one)^1,5,10. Additionally, Beovu showed superior reductions in central subfield thickness, another indicator of retinal fluid, at week 16 and at year one^1,5. Differences seen at year one were maintained at year two^1,5. In both trials, 30% fewer patients had signs of disease activity with Beovu versus aflibercept as early as week 16¹¹.

In HAWK and HARRIER, over half of patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER) at year one^1,5. The remaining patients in the study were treated on a two-month dosing interval^1,5.

“Today’s approval is a step forward for patients in Europe who have been looking for a new treatment option which may help them maintain their sight — and their independence — for longer,” said Christina Fasser, President, Retina International. “This can really help to alleviate a burden, not only on the patient themselves, but also on those who care for them."

In October 2019, Novartis received approval from the U.S. Food and Drug Administration for Beovu for the treatment of wet AMD¹². Beovu received Swissmedic approval in Switzerland¹³ and Australian TGA approval¹⁴ in January 2020, both for the treatment of wet AMD. Novartis is committed to bringing Beovu to patients worldwide, and additional regulatory filings are currently underway in Canada, Japan and Brazil.

About Beovu (brolucizumab)
Beovu (brolucizumab, also known as RTH258) is the most clinically advanced humanized single-chain antibody fragment (scFv)^5,15. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics^15-17.

The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms¹⁶. Beovu is engineered to deliver the highest concentration of drug, providing more active binding agents than other anti-VEGFs^5,15. In preclinical studies, Beovu inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction^16-18. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema¹⁹. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions and suppress endothelial cell proliferation and vascular permeability¹⁹.