1. Oct 09, 2019

Beovu® Receives FDA Approval for Wet AMD

Novartis announced Beovu® (brolucizumab) has been approved by the US Food & Drug Administration for wet age-related macular degeneration (AMD). It is the first anti-VEGF to provide greater fluid resolution versus aflibercept and helps maintain patients with wet AMD on a 3-month dosing interval immediately after a 3-month loading phase.

Beovu’s molecule was developed to deliver the highest concentration of drug, providing more active binding agents than other anti-VEGFs. Because of this, it is able to better suppress growth of abnormal blood vessels and fluid leakage in the retina.

The approval was based on findings from the Phase III HAWK and HARRIER clinical trials, which included >1,800 patients across 400 centers worldwide. Beovu demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year 1.

In both trials, approximately 30% of patients gained 15 letters at year 1. Beovu also showed greater reduction in central subfield thickness and less instances of intra-retinal and/or sub-retinal fluid.

Marie-France Tschudin, President, Novartis Pharmaceuticals, said, “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.”

Novartis is now offering BEOVU Your WayTM, giving personalized, one-on-one support for patients and caregivers. The goal is to empower patients with wet AMD to live safely and independently.

You can read more here.