According to the June 9, 2020, FDA Beovu label change approval letter: “This Prior Approval supplemental biologics application provides for the addition of ‘Retinal Vasculitis and/or Retinal Vascular Occlusion’ to the Warnings and Precautions section of the Prescribing Information.”
This Beovu label change comes after postmarketing reports of these Beovu vision-loss side effects such as retinal vasculitis. Several news articles reported the following related points:
- The Beovu label change is based on a recent internal review conducted by Novartis of adverse events observed in the HAWK & HARRIER clinical trials, including rare postmarketing safety reports of vasculitis.
- In connection with its Beovu label change, Novartis stated that a review of these postmarketing events concluded that “there is a confirmed safety signal of rare adverse events termed as ‘retinal vasculitis’ and/or ‘retinal vascular occlusion’ that may result in severe vision loss.”
As background, the FDA approved Beovu for the treatment of wet AMD on October 8, 2019.
We are currently investigating drug injury lawsuits against Novartis for Beovu causing vision loss and blindness due to retinal vasculitis, retinal vascular occlusion, and intraocular inflammation.
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