FDA approves Novartis’ Beovu injection for wet age-related macular degeneration

pharmafile | October 8, 2019 | News story | Manufacturing and Production, Sales and Marketing Beovu, Eylea, FDA, Novartis, Regeneron, pharma 

Novartis has secured FDA approval for its Beovu (brolucizumab) injection in the treatment of wet age-related macular degeneration (AMD), it has emerged.

The decision makes it the first anti-VEGF drug approved by the FDA to “maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy”, while also offering greater fluid resolution compared to Regeneron’s Eylea (aflibercept).

According to data from two Phase 3 trials submitted in support of the application, Beovu was shown to be non-inferior to Eylea in mean change in best-corrected visual acuity at year one, with 30% of participants gaining 15 or more letters  over that period in both studies. Patients taking the drug also experienced greater reduction in central subfield thickness (CST) as early as week 16 and at year one, while fewer patients had intra-retinal (IRF) and/or sub-retinal fluid (SRF).

Caused by an excess of the VEGF protein leading to abnormal blood vessel growth beneath the centre of the retina, wet AMD affects clarity of central vision and can eventually lead to blindness. By 2020, it is forecast that 1.75 million US citizens will be affected by the condition.

“Beovu meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid,” explained Dr Pravin U Dugel, Managing Partner at Retinal Consultants of Arizona; Clinical Professor, Roski Eye Institute, Keck School of Medicine, University of Southern California; and principal investigator of the HAWK clinical trial. “With Beovu, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas. Coupled with the potential to treat patients with quarterly injections, this approval may change the way we approach the treatment of wet AMD.”

Marie-France Tschudin, President of Novartis Pharmaceuticals, added: “The approval of Beovu delivers on the Novartis commitment to reimagining treatments for patients suffering from serious visual impairment. 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.”

Matt Fellows

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