The US Food and Drug Administration (FDA) has approved a label update for Beovu® (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion, Novartis reports. Beovu (brolucizumab, also known as RTH258) is a clinical humanized single-chain antibody fragment (scFv) inhibitor of VEGF-A for the treatment of wet AMD.
The update to the US label includes the addition of a sub-section dedicated to retinal vasculitis and/or retinal vascular occlusion under ‘Warnings and Precautions’ (section 5). It also specifies that these adverse reactions are part of a spectrum of intraocular inflammation rates from the Phase III HAWK & HARRIER trials.
This approval follows Novartis’ announcement that it would pursue worldwide label updates after a review and further characterization of rare post-marketing safety events reported to Novartis. Novartis has established a fully dedicated internal team collaborating with top global experts (a coalition) to examine the root causes, risk factors, mitigation and potential treatment protocols.
A Safety Review Committee established by Novartis noted that the overall rate of vision loss in the study population was similar between the Beovu and aflibercept arms in HAWK & HARRIER despite the risk of vision loss associated with the adverse events.
“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. “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.”
Full news release: https://www.novartis.com/news/media-releases/us-fda-approves-updated-novartis-beovu-label-include-additional-safety-information