Novartis (NVS)

[DewDiligence]

NVS concedes Beovu has new safety issue:

https://www.brolucizumab.info/

Novartis has now completed its review of these post-marketing safety case reports… Based on internal and SRC assessment, it was concluded that there is a confirmed safety signal of rare adverse events of “retinal vasculitis and/or retinal vascular occlusion with or without presence of intraocular inflammation that may result in severe vision loss.”

Based on this review, Novartis has initiated a safety information update to Beovu prescribing information worldwide. Currently approved prescribing information includes intraocular inflammations, visual acuity decrease (including blindness) and retinal artery occlusion as separate terms. We will work with regulatory authorities to finalize the prescribing information update.

In addition, we are working with our data monitoring committees and informing investigators of ongoing clinical trials. Novartis-sponsored studies will be amended so that protocols, Informed Consent Forms and Investigator Brochures reflect this new safety information. Investigators are also being informed to re-consent patients.