Novartis’ Beovu approved in Europe after outclassing Eylea in wet age-related macular degeneration

pharmafile | February 18, 2020 | News story | Manufacturing and Production, Sales and Marketing Beovu, Eylea, Novartis, Regeneron, macular degeneration, pharma 

The European Commission (EC) has chosen to approve Novartis’ Beovu (brolucizumab) injection, it has emerged, as a treatment for wet age-related macular degeneration (AMD).

The decision marks the availability of the first anti-VEGF in Europe to outclass Regeneron’s Eylea (aflibercept) in terms of resolution of retinal fluid (IRF/SRF), a key marker in AMD, and follows the FDA’s decision to authorise the therapy back in October 2019.

Phase 3 data submitted in support of the application showed that Novartis’ drug met its primary endpoint after proving non-inferior to Eylea in terms of gains in best corrected visual acuity at 48 weeks of treatment, with such gains maintained through a full second year.

Furthermore, 31% of Beovu patients displayed intra-retinal and/or sub-retinal fluid (IRF/SRF) compared to 45% of Eylea patients, falling to 26% and 44% after a year of treatment, while Beovu also showed ”superior reductions” in central subfield thickness compared to Eylea after 16 weeks and one year of treatment.

 Additionally, Novartis confirmed that 30% fewer patients taking Beovu showed signs of disease activity compared to Eylea after 16 weeks of treatment.

Another key benefit of Beovu, Novartis said, is that it provides eligible AMD patients with the option to start treatment on a three-month dosing interval immediately following the loading phase.

“Currently, wet AMD patients, who are often older, can face significant challenges in managing their disease. We believe that Beovu, and its ability to resolve fluid, brings great therapeutic value that will help physicians optimise treatments for patients based on disease activity,” commented Marie-France Tschudin, President  of Novartis Pharmaceuticals. “With the approval of this innovative biologic, Novartis is continuing to reimagine medicine for people living with wet AMD.” 

Matt Fellows

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