US FDA approves updated Novartis Beovu label to reflect safety data

The US Food and Drug Administration has approved a label update for Beovu (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion, says Swiss pharm giant Novartis (NOVN: VX), whose share were down 1.4% at 82.52 Swiss francs by late morning today.

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.