'Lightning struck': How a safety alert shifted doctor sentiment on Novartis' Beovu

Following an FDA approval back in October, Novartis was off and running with its important new launch Beovu to treat wet age-related macular degeneration. But, after a safety alert from experts last month, a lot has changed, an analyst found.

On a Sunday night in February, the American Society of Retina Specialists (ASRS) sent out a safety update to doctors detailing 14 cases of retinal vasculitis for Beovu patients, 11 of which were occlusive retinal vasculitis that can lead to vision loss. The alert came early into the launch, so many of the patients had only had either their first or second injection.

Now, docs’ views of the med are dramatically different than before the communication, Piper Sandler analyst Christopher Raymond wrote in a note to clients. The team had conducted a survey of 30 doctors right before the ASRS communication, and the experts said Beovu would reach 17% market share by August.

In another survey right afterward, their perception of the drug had been damaged. The docs now project Beovu to hold 8.4% of the patient share by August. And there’s now “anger and mistrust of [Novartis], indicating an uphill battle" for the launch.

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Before, doctors believed Novartis’ new option offered better efficacy and an improved dosing schedule versus Regeneron’s Eylea, Raymond wrote.  

“Then lightning struck,” he added. “The world changed with the ASRS communication regarding cases of occlusive vasculitis in Beovu treated patients.”

Novartis is standing behind the drug. While its review is ongoing, the Swiss drugmaker said its initial look at the data still support a positive benefit-risk profile. Novartis said the drug’s label describes the safety risk and that doctors shouldn’t use the medicine in patients with intraoccular inflammation. Patients who show certain symptoms should get immediate care, the company said.

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While the safety risks are discussed on Beovu’s label, many doctors rely on sales reps and messaging from the company instead of reading the package inserts for themselves, Raymond wrote.

Meanwhile, Beovu's pain is Eylea's gain, he said. The team projects Regeneron's drug will generate $5 billion in the U.S. this year, followed by $5.3 billion in 2021 and $5.46 billion in 2022.