Beovu Gets FDA Label Update With Warnings


Novartis reported that the FDA has approved a label update for Beovu (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion. This approval follows the announcement by Novartis that it would pursue worldwide label updates after a review and further characterization of rare postmarketing safety events reported to Novartis.

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." It also specifies that these adverse reactions are part of a spectrum of intraocular inflammation rates from the phase 3 HAWK and HARRIER trials. The company has also established an internal team collaborating with global experts to examine the root causes, risk factors, mitigation, and potential treatment protocols.

“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 news release.