Novartis' Beovu (brolucizumab) Receives EMA's Approval for its Safety Label Update to Treat Wet Age-Related Macular Degeneration
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- The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion- usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of update to the Beovu prescribing information globally
- The label update is applicable to all 27 EU member states as well as UK- Iceland- Norway- and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US- EU- UK- Japan- Canada- and Australia
- Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) which enhances tissue penetration- rapid clearance from systemic circulation and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause- potential risk factors and mitigation of AEs
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