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Novartis : FDA Oks Updated Beovu Label To Include Addl Safety Information

Novartis (NVS) said Thursday that the US Food and Drug Administration has approved a label update for Beovu or brolucizumab to include additional safety information regarding retinal vasculitis and retinal vascular occlusion.

The update to the US label included the addition of a sub-section dedicated to retinal vasculitis and/or retinal vascular occlusion under 'Warnings and Precautions.' It also specifies that these adverse reactions are part of a spectrum of intraocular inflammation rates from the Phase III HAWK & HARRIER trials.

Beovu was approved in the US in October 2019 for the treatment of wet age-related macular degeneration (AMD), based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year one.

Novartis today said it has convened a fully dedicated team collaborating with top global external experts, leveraging the collective multidisciplinary expertise to examine the root causes, potential risk factors and mitigation of these adverse events.

A Safety Review Committee established by Novartis noted that the overall rate of vision loss in the study population was similar between the Beovu and aflibercept arms in HAWK & HARRIER despite the risk of vision loss associated with the adverse events of interest.

The company said it is confident that Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit/risk profile.

Wet AMD is the leading cause of severe vision loss and legal blindness in people over the age of 65 in North America, Europe, Australia and Asia. Wet AMD occurs when abnormal blood vessels form underneath the macula, the area of the retina responsible for sharp, central vision. These blood vessels are fragile and leak fluid, disrupting the normal retinal architecture and ultimately causing damage to the macula.

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