We had been watching for a second Beovu label change since May 2021, when Novartis stopped three Beovu clinical trials for safety reasons, and, at the same time, said it would update the Beovu drug label. Finally, in February 2022, Novartis added information and increased safety warnings about various Beovu side effects, such as retinal vasculitis, retinal vascular occlusion, and retinal artery occlusion. The first Beovu label change happened back in June 2020.
So that people can draw their own conclusions about what this February 2022 Beovu label change means as regards the lingering Beovu safety issues mentioned at the outset, and to be able to compare the Beovu Prescribing Information “Revised: 2/2022” document with the earlier “Revised: 6/2020” version, we direct you to this FDA webpage “Drug Safety-related Labeling Changes (SrLC) for Beovu (brolucizumab-dbll)“.
There you will see the extent of revisions made to the three parts that are identified in the “Recent Major Changes” section of the new 2022 Beovu drug label:
- 5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion
- 6.1 Clinical Trials Experience
- 6.2 Immunogenicity
As background, Beovu was approved by the FDA in 2019 as a treatment for neovascular (wet) age-related macular degeneration (AMD). Since then, there have been reported cases of Beovu eye-related side effects such as retinal vasculitis, retinal vascular occlusion, or retinal artery occlusion leading to vision loss. We have followed these Beovu safety issues for the past two years, and we will continue to watch for further developments concerning Beovu eye-related side effects such as retinal vasculitis, retinal vascular occlusion, and retinal artery occlusion.
As we have reported previously, starting in January 2021, Beovu lawsuits have been filed for patients alleging that Novartis failed to warn doctors and patients about these Beovu vision loss side effects in a timely manner. As mentioned at the outset, there was a first Beovu label change in June 2020 and, now, a second Beovu label change in February 2022.
We continue to investigate Beovu drug injury lawsuits against Novartis where there has been vision loss due to retinal vasculitis, retinal vascular occlusion, or retinal artery occlusion after patients received their Beovu injections.[Read article in full at original source]