FDA to update Beovu label to include additional safety information

The FDA approved a label update for Beovu to include safety information about retinal vasculitis and retinal vascular occlusion, according to a Novartis press release.
The label update follows a Novartis announcement that it would pursue worldwide label updates to Beovu (brolucizumab-dbll). The U.S. label update, under “Warnings and Precautions,” will include a subsection about retinal vasculitis and/or retinal vascular occlusion.
The update specifies that the adverse events are “part of a spectrum of intraocular inflammation rates from the phase 3 HAWK and HARRIER trials,”

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