European Medicines Agency (EMA) approves safety label update for Novartis Beovu

• 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 inflammation¹
   
• Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors and mitigation of these adverse events
   
• Novartis is confident that Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit/risk profile 

Basel, September 14, 2020 — Novartis announced today 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 occlusion¹. 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 managed¹.

“This label update is one of the many efforts Novartis is taking to help physicians make informed decisions,” said Marcia Kayath, Global Head of Medical Affairs and Chief Medical Officer, Novartis Pharmaceuticals. “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.”