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,” according to the release.
Novartis received reports of vasculitis in 14 patients treated for wet age-related macular degeneration with Beovu since its approval by the FDA in October 2019. The company initiated an internal review of the case reports and established an external safety review committee, which confirmed a safety signal of rare adverse events termed as “retinal vasculitis” and/or “retinal vascular occlusion.”