Novartis completes safety review and initiates update to the Beovu prescribing information worldwide.

As part of its safety surveillance program, Novartis has been actively evaluating post-marketing cases reported as severe vision loss, retinal artery occlusion and/or vasculitis with Beovu (brolucizumab). The company has been working closely with the reporting physicians and retina specialists to get their perspective and collect the relevant clinical and imaging data in a manner compliant with regulatory requirements.

Novartis has now completed its review of these post-marketing safety case reports. This included assessment by an external Safety Review Committee (SRC) chartered to provide independent, objective and thorough scientific review of the reported post-marketing adverse events in comparison to relevant events seen in the Phase III Hawk and Harrier registration trials that were the basis of the approved prescribing information. 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. Novartis will work with regulatory authorities to finalize the prescribing information update.

In addition, the company is working with its 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. Novartis is committed to continuing to collaborate with the scientific and broader retina community to better understand the root causes and potential risk factors associated with these rare adverse events. Novartis continues to believe Beovu represents an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile.

Comment: In its new review of post-market adverse events reporting, Novartis found retinal artery occlusion, inflammation of blood vessels in the eye — known as vasculitis — or severe vision loss, occurred in 8.75 to 10.08 out of 10,000 injections for five weeks spanning 28 February.to 27 March . Events causing severe vision loss such as uveitis or cataracts were most common, occurring at a rate of as high as 4.03 per 10,000 injections in the week of 6 March

Novartis said it will work with FDA, the European Medicines Agency and other national regulators to amend the product label, as well as change the protocols of ongoing clinical trials to prevent such adverse event.

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