Novartis Updating Beovu Labeling Over Safety Signal

Novartis says it has confirmed a safety signal with Beovu (brolucizumab) involving “retinal vasculitis and/or retinal vascular occlusion with or without presence of intraocular inflammation that may result in severe vision loss.” Beovu is a human vascular endothelial growth factor inhibitor indicated for treating neovascular (wet) age-related macular degeneration. The company says it is working with FDA and other global regulatory agencies to update the drug’s prescribing information worldwide. “Currently approved prescribing information includes intraocular inflammations, visual acuity decrease (including blindness) and retinal artery occlusion as separate terms,” the company says.

Novartis also says it is working with its data monitoring committees and informing investigators associated with ongoing clinical trials. Company-sponsored studies will be amended so that protocols, informed consent forms and investigator brochures reflect the new safety information, it says.