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Novartis provides safety update for Beovu

A safety review into Novartis’ new anti-VEGF drug Beovu has revealed that reported adverse events are consistent with the approved prescribing information after a group of US retinal specialists linked it to a series of vasculitis cases.

Last month, the Swiss drug giant launched comprehensive internal review into reports that Beovu (brolucizumab) was associated with severe vision loss, retinal artery occlusion and/or vasculitis in patients, including cases where they had previously received other anti-VEGF therapies.

It came after an alert from the American Society of Retinal Specialists (ASRS) to its members concerning 14 reported cases of vasculitis after Beovu injections. Of those, 11 were said to have occlusive retinal vasculitis.

In response, Novartis stated it stood behind the safety and efficacy of Beovu when used as indicated. However, it launched the safety review and said it would work closely with the reporting physicians and retina specialists to understand what occurred.

It also engaged its data monitoring committee for its ongoing global trials. An external safety review committee was also established to further evaluate the post-marketing cases.

In an update on 11 March, the company revealed the data continued to support an “overall favorable benefit-risk profile for Beovu”. The prescribing information leaflet for Beovu in the US states a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion.

“The rate of the reported post-marketing events remains consistent with or below the approved prescribing information. In the registration trials, the incidence of vision loss was comparable between Beovu and aflibercept [Eylea],” a Novartis press release said.

“Currently, there is no validated new or changed safety signal. We are conducting an ongoing assessment of the onset and severity of the reported post-marketing events in comparison to those observed in the clinical trials.”

Novartis has since launched a new website – to be updated weekly – that details the rates of clinically significant adverse events for Beovu.

Beovu is approved for the treatment of neovascular age-related macular degeneration by the US Food & Drug Administration, the European Commission, Swissmedic and the Australian Therapeutic Goods Administration. Its safety has been demonstrated in a Phase 3 program, including more than 1,800 patients worldwide across 400 study sites.

In Australia, Novartis is pursuing a Pharmaceutical Benefits Scheme (PBS) listing for Beovu. However, at a meeting in November an independent advisory committee did not recommend the therapy noting the higher incidence of serious ocular adverse events reported for brolucizumab (Beovu) compared with aflibercept (Eylea) in the clinical studies. It considered the claim of non-inferior safety “uncertain.”

Novartis made a resubmission for consideration at a March 2020 meeting. The outcome will be published to the PBS website on 24 April.