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

Beovu drug box
Novartis won approval for new wet age-related macular degeneration drug Beovu in October. (Novartis)

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.

Free Webinar

Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. In this webinar, learn the benefits of utilizing demand-led supply and direct-to-patient distribution models in the clinical supply chain, as well as how they can be used to both improve flexibility and better align with patient needs. Register today!

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.

RELATED: Novartis' hot new eye drug Beovu tied to potential vision loss: experts 

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.

RELATED: Novartis stands behind Beovu's safety, benefits after vision-loss warning 

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.

Suggested Articles

Former Indivior CEO Shaun Thaxter will face six months in federal prison for his role in misleading government officials on the dangers of Suboxone.

As of Friday after local time, 36 people have died in Korea after getting flu shots provided by at least seven companies, including Sanofi.

Two prominent pneumococcal vaccines from Merck and Pfizer are running low in Europe in a possible ill omen for the coming winter: report.