Novartis takes on Regeneron, Roche blockbusters with Beovu approval

Novartis won its first approval for Beovu worldwide, scoring an FDA nod. (Novartis)

Look out, Regeneron and Roche. Novartis has the FDA go-ahead for its next blockbuster launch in Beovu, a drug for wet age-related macular degeneration (AMD) that beat out Regeneron's big-selling Eylea on some measures in a head-to-head trial.

Novartis' Beovu won FDA approval Tuesday to treat wet AMD, a condition expected to affect 1.75 million people in the U.S. next year. 

In addition to Eylea, the med threatens Roche's Lucentis, which Novartis itself markets in Europe. That drug loses European patent protection in 2020, so Novartis expects to launch Beovu in Europe as Lucentis faces copycats there.

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The Swiss drugmaker priced the drug at $1,850 per vial, a spokesman said. That’s on par with the competition, as Eylea carries a list price of $1,850 per vial and Lucentis costs $2,000 per vial, according to reports.

Despite existing options, wet AMD is still a burden for patients and caregivers, Marcia Kayath, Novartis’ global head of medical affairs, said. Some patients need to go to the office once a month, and many patients drop off their treatment due to burdens associated with current drugs

Beovu, though, can treat patients on a quarterly basis or every other month, Kayath noted. And in clinical trials, it showed it could “achieve superior fluid resolution with less injections” than Eylea and achieve vision gains.

Doctors in the field have told Novartis they expect to switch patients who are getting suboptimal care from current drugs or those that have to their offices frequently, according to Kayath; they also expect to start many new patients on Beovu given clinical data showing the new drug can control the disease with visits once every 12 weeks. 

The drug won approval for 8- and 12-week dosing intervals after a three-month loading phase of monthly injections. But SVB Leerink analysts pointed out that the label carries “higher safety liabilities” than Eylea. In the phase 3 trials, patients on Beovu were four times as likely to have intraocular inflammation than those on Eylea, at 4% and 1%, respectively.

The analysts see that factor as Regeneron’s “main defense" in the indication.

“While [Novartis] and Beovu are certainly going to be strong competitors, we expect that Eylea can still grow for another year or two,” the analysts wrote in a note to clients.

RELATED: Novartis' speedy brolucizumab review tees up battle with Eylea, Lucentis 

Beovu was one drug OptumRx experts recently highlighted as a major launch coming from pharma yet this year. With Eylea and Lucentis both facing 2020 patent expirations, biosimilars could eat away at pricing in the field as Novartis seeks to grow sales for its new offering. Still, analysts expect the drug to generate more than $1 billion and top the market by 2026. 

Novartis used a priority review voucher on its Beovu application, indicating how eager the drugmaker is to get started with the launch. Beovu's rollout follows another major approval for the company in May for Zolgensma, its gene therapy to treat spinal muscular atrophy, and its Mayzent multiple sclerosis go-ahead in March. 

RELATED: Novo's Rybelsus, check. Here are the major launches coming up next 

Beovu won approval based on two studies that pitted the drug against Eylea to show the new med could match up with the blockbuster on efficacy. The drug topped Eylea on secondary endpoints that looked at retinal fluid and central subfield thickness. One expert previously told Jefferies analyst Biren Amin that “retinal dryness and slightly reduced injection burden were incremental advances but not game-changers.” But Novartis will look to capitalize on its med's advantages.

Meanwhile, Roche is advancing its own next-gen wet AMD candidate called faricimab in phase 3. Regeneron recently won a diabetic retinopathy nod for Eylea, enabling it to keep pushing for growth amid the new competition.

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