Analysts at Jefferies suggested that a recent update on the safety of Novartis' Beovu (brolucizumab) may hamper initial uptake of the wet age-related macular degeneration (AMD) treatment. The injectable anti-VEGF therapy gained approval in the US last October, with clearance in Europe granted earlier this month.
However, the American Society of Retina Specialists (ASRS) issued an update on February 23, indicating that since Beovu's launch in the US, there have been 14 cases of vasculitis associated with the drug, including 11 reported to be occlusive retinal vasculitis. The ASRS noted that around 46,000 Beovu injections have been administered to-date in the US.
Jefferies analysts subsequently did a search in the FDA Adverse Event Reporting System (AERS) database and found that since Beovu's launch in November, 36 serious cases have been reported to AERS, with two cases of vasculitis, six of blindness and four involving eye inflammation. Comparing the figures to those for Regeneron Pharmaceuticals' Eylea (aflibercept) in the first year of launch, as well as in the period from last November to this month, they said "the incidence in patients treated with Beovu [is] consistently higher than those with Eylea." The analysts noted that in Phase III trials, Beovu was associated with intraocular inflammation and blindness in 4% and 1% of patients, respectively, although retinal vasculitis was not reported.
They also cited feedback from two retina specialists, with one having administered 170 Beovu injections without any reports of adverse events so far. Still, due to potential legal risks, "this doctor is switching most of his patients back to other anti-VEGF therapies," Jefferies analysts said. The analysts expect "these safety concerns are likely to dampen retina physicians' initial uptake of Beovu…with many perhaps now waiting until their initial switched patients have received more injections of the drug before re-considering wider adoption." They added that the safety concerns surrounding Beovu will also likely "[minimise] competitive risk" to the Eylea franchise.
In response, Novartis said it was aware of recently reported adverse effects of the drug, but that it "stands behind the safety and efficacy of Beovu." Approval of Beovu was based on findings from the Phase III HAWK and HARRIER studies, which showed that the drug "continued to be comparable to Eylea with the overall incidence of adverse events" after 96 weeks, Novartis said in 2018. The Swiss drugmaker indicated on Tuesday that "in addition to our own internal assessment, we have engaged an external safety review committee to further evaluate these post-marketing cases. We will continue to share details as they become available."
Analysts at Jefferies retained their annual peak sales forecast for Beovu, with worldwide revenue from the drug seen hitting $2.5 billion, but they suggested that "the long-term impact" of the safety issues on the drug's sales is "dependent on the outcome of the review." Novartis reported late last month that Beovu had sales of $35 million since it entered the market in the fourth quarter, noting at the time that "initial launch uptake has been strong and broad access has been established."
Meanwhile, Jefferies analysts raised their estimates for Eylea, adding they are ahead of consensus by $180 million in 2020 and $450 million in 2021 and 2022, respectively. Regeneron reported earlier this month that US net sales for Eylea in the fourth quarter were 13% higher versus the year-ago period at $1.2 billion.
For related analysis, see Physician Views snap-poll results: Four in ten ophthalmologists predict high rate of use for Novartis' Beovu, and KOL Views Results: Leading retinal specialist expects a slow rollout, but sees big potential in Novartis' Beovu.
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