Novartis gets approval for quarterly dosing wet AMD treatment

09-Oct-2019 - Last updated on 09-Oct-2019 at 15:26 GMT

(Image: Getty/Fizkes)

Novartis receives approval from the US FDA for its treatment for wet AMD, which could set Beovu apart in a competitive field.

The Swiss company becomes the first to receive approval for a treatment of wet age-related macular degeneration (AMD) with a dosing schedule of every three months, after a three-month loading phase.

In clinical trials that supported Novartis’ application to the US Food and Drug Adminsitration (FDA), Beovu (brolucizumab) injections were able to show non-inferiority in comparison to Regeneron’s Eylea (aflibercept), which has a dosing schedule of every two months.

In terms of how its treatment achieves this, the company stated that the monoclonal antibody (mAb) is able to deliver more active binding agents allowing for higher concentration of the drug compared to other anti-vascular endothelial growth factor (VEGF) therapies.

The company stated that frequent injections are a common reason that patients drop off treatment for their condition, which can lead to blindness. The longer interval between injections therefore may increase patient adherence to the treatment.

Other companies in the area have explored alternative routes for ensuring that patients do not have to go through frequent injections, such as Genentech’s development of an implant that is able to deliver Lucentis (ranibizumab) directly into the eye and requires refilling after six or more months.

Competitive market

Lucentis represents Novartis existing foothold in the anti-VEGF category, which it markets alongside fellow Swiss company, Roche.

In terms of sales, Lucentis brought in $536m (€488m) for Novartis in the second quarter of this year, through its rights to commercial sales in ex-US territories.

GlobalData projects sales of Beovu could reach approximately $4.1bn annually by 2026, while sales of Regeneron’s Eylea are expected to fall through competition with Novartis’ product.

Ahead of its regulatory submission to the FDA, Novartis had scaled up its production to meet commercial demand, as well as providing enough capacity for potential further indications that the product may add to its label.