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European Medicines Agency Approves Safety Label Update For Novartis' Beovu - Quick Facts

Novartis AG (NVS) announced Monday that the Committee for Medicinal Products for Human Use (CHMP), has approved an update to the Beovu (brolucizumab) Summary of Product Characteristics (SmPC) to include additional information regarding retinal vasculitis and retinal vascular occlusion.

Typically, these events occurred in the presence of intraocular inflammation. This approval follows Novartis' announcement that it would pursue worldwide label updates after a review and further characterization of post-marketing safety events reported to Novartis.

Novartis worked with the EMA to update the Beovu (brolucizumab) label to guide physicians in their treatment of wet AMD. The update includes the additional characterization of retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation

The label update is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein. Beovu is now approved for the treatment of wet AMD in more than 40 countries, including in the US, EU, UK, Japan, Canada and Australia.

Beovu (brolucizumab, also known as RTH258) is the most clinically advanced humanized single-chain antibody fragment (scFv). It is approved in more than 40 countries, including in the US, EU, UK, Japan, Canada and Australia, based on the results of the HAWK and HARRIER clinical trials.

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