Novartis supply-ready for approved wet AMD antibody fragment

Novartis says it is confident in its ability to supply Beovu (brolucizumab) after the single-chain antibody fragment received US FDA approval for treating wet AMD.

The US Food and Drug Administration (FDA) this week approved Novartis’ anti-VEGF product Beovu for the treatment of patients with wet age-related macular degeneration (AMD) on a three-month dosing interval.

A Novartis spokesperson did not divulge where the antibody fragment is made but told this publication the firm is confident in its ability to meet demand. The vial formulation, meanwhile, is made in Novartis’ native Switzerland, we were told.

Image: iStock/Shidlovski

The treatment will cost $1,850 per vial, according to Evaluate, putting it on par with Regeneron’s rival wet AMD biologics Eylea (aflibercept) and slightly less than Roche’s Lucentis (ranibizumab) – marketed in Europe by Novartis itself.

However, Novartis expects to gain a serious slice of the wet AMD market – estimated to be worth up to $11.5 billion by 2026 – despite competing against Eylea, Lucentis, Roche’s Avastin (bevacizumab), and various biosimilars of these in development. This is because it aims to provide wet AMD patients with “robust vision gains, superior fluid resolution and fewer injections vs aflibercept,” the Novartis spokesperson told us.

“Fluid in the retina is a sign of disease activity and retinal specialists treat based on a number of factors including visual acuity and fluid. In the HAWK and HARRIER clinical trials, greater reductions in central subfield thickness (CST) were seen with Beovu as early as week 16 and at year one.

“Beovu is the only anti-VEGF for wet AMD treatment recommended to maintain eligible patients on up to three-month dosing intervals immediately after the loading phase, which means many patients may have a longer time between treatments.

“Each injection, which may be as frequent as every month with current therapies, involves transportation and logistics hassles for patients and their caregivers. These are some of the factors that lead to treatment drop-off and the eventual loss of vision gains.”