FDA approves update to Beovu label to include additional safety information
The U.S. Food and Drug Administration has approved a label updated for Beovu (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion.
“This label update provides clinicians with important information to guide treatment decisions. We believe Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile,” said Marcia Kayath, Global Head of Medical Affairs and Chief Medical Officer, Novartis Pharmaceuticals, in a press release. “We remain grateful to all doctors who have taken the time to share their expertise and treatment experience to contribute to the collective understanding of these safety events. As we proceed to examine root causes and potential mitigation strategies, we will continue to communicate findings with transparency and urgency to regulatory bodies and healthcare providers.”
Beovu received FDA approval in October 2019 for the treatment of wet age-related macular degeneration (AMD).
Read the full press release here.