European Medicines Agency (EMA) Approves Safety Label Update for Novartis’ Beovu

Source: Novartis

Novartis announced 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.1 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.

The update to the EU label includes the addition of retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation under “Special warnings and precautions for use” (section 4.4) and “Undesirable effect” (section 4.8). The label notes that patients developing these events should discontinue treatment and the events should be promptly managed.1

“This label update is one of the many efforts Novartis is taking to help physicians make informed decisions,” Marcia Kayath, Global Head of Medical Affairs and Chief Medical Officer, Novartis Pharmaceuticals, said in a company news release. “Novartis is committed to fully understanding and transparently communicating the safety profile of Beovu. To this purpose, we have established a coalition, which is a fully dedicated internal team collaborating with top global experts to examine the root cause, risk factors, mitigation and potential treatment recommendations.”

The label update is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.1 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.

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