US FDA approves updated Novartis Beovu® label, to include additional safety information

 

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Basel, June 11, 2020 — Novartis announced today that 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. 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. This is one of many efforts Novartis is taking to help physicians to make informed decisions on the use of Beovu, including the establishment of a fully dedicated internal team collaborating with top global experts (a coalition) to examine the root causes, risk factors, mitigation and potential treatment protocols.

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 (Table 1).

“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.”

Beovu was approved in the US in October 2019 for the treatment of wet age-related macular degeneration (AMD), based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year one (week 48). Beovu demonstrated the ability to maintain a majority of patients on a three-month interval immediately after the loading phase