Sanofi and Regeneron just added another building block to a nascent immunology franchise expected to bring in $5 billion or more by 2022. But to get there, their new Kevzara will have to go up against a host of other rheumatoid arthritis meds already on the market—and a few still on their way.
One way Kevzara can do that? A lower price, according to doctors surveyed by GlobalData analysts. And Kevzara will have a list price of $39,000 per year, the companies say, 30% lower than the two most widely used TNF-alpha drugs, which will be among its chief competitors.
Kevzara's nod comes more than six months after the FDA turned back the drug on manufacturing problems at a Sanofi plant where drugs are filled and finished. The two companies worked with the agency to fix them, and after a successful inspection earlier this year, the Kevzara approval was widely expected.
Kevzara (sarilumab) is Sanofi and Regeneron’s second entry into the immunology field, after the approval of Dupixent, a treatment for severe eczema, in March. The two meds—with sales estimates of $1 billion-plus and up to $4 billion, respectively—are key to both companies’ top-line futures, at a time when the growth of Regeneron’s vision-loss blockbuster Eylea is slowing and Sanofi’s top-selling diabetes treatment, Lantus, faces its first biosimilar and a range of other new competitors.
Kevzara, an interleukin-6 receptor antibody, will be entering a tough market. It will have to jockey for share with well-established TNF-alpha inhibitors—such as the world’s best-selling drug, Humira—and other IL-6 drugs, including Roche’s older Actemra and the forthcoming Johnson & Johnson/GlaxoSmithKline med sirukumab, with its decision date in the third quarter.
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But Kevzara has some promising data to its credit, and Sanofi’s clinical research lead on the drug, Jonathan Sadeh, pointed out that rheumatoid arthritis patients could use more options for treatment. They’re often diagnosed in their 40s and 50s, and need treatment for a lifetime.
“Patients with RA have decades of life to live with the disease, so it’s important for physicians to have multiple modalities to use over time,” Sadeh said in an interview.
Patients tend to start on a biologic therapy, most commonly a TNF-alpha drug, and their disease is controlled only for a period of time, he said. Or they may respond inadequately—or not at all.
“At that point what happens is physicians cycle from one TNF to another,” Sadeh said. “What has been shown is that in those patients, it is better to switch to different mechanisms of action. … That’s a perfect situation where we’d like to see physicians look for a new mechanism of action and switch to Kevzara.”
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Some physicians tend to be wary of newer meds, however, and those skeptics say they’ll put upcoming rheumatoid arthritis launches in line behind other drugs they know better, according to a GlobalData market analysis. But price could make a difference.
"Unless we can upfront identify a group in whom [a new drug] is going to be effective … [or] unless it’s marketed at a significantly lower cost than its competitors, what will happen is that the drug will be used fourth or fifth line," one specialist told the market research firm.
So Sanofi and Regeneron’s task will be persuading doctors that Kevzara stands out from the pack, and it has a range of studies it hopes can help. For instance, the drug beat Humira in a head-to-head study comparing each of the drugs as monotherapy. By contrast, sirukumab met only one of the endpoints when pitted against Humira.
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Kevzara has also shown it can stall progression of joint damage as shown with radiographic imaging, which Sanofi sees as key to its benefits for patients, Sadeh said. The drug showed “great efficacy” in reducing symptoms and improving physical function, Sadeh said. “But the most important point is [its ability to] control radiographic progression of structural damage.”
In immunology, a drug’s first approval is often just the beginning, and Kevzara’s development partners hope the same will prove true for Kevzara. The drug is in phase 2 testing for uveitis, an inflammatory eye condition that can lead to vision loss, and Sadeh said Sanofi plans to study it in other diseases. “There are none on the books right now, but in future we will study multiple other indications,” he said.
Sadeh wouldn’t say which other diseases Kevzara might go up against, but did say that the IL-6 drug will likely target some conditions its TNF-alpha rivals aren’t approved to treat. The two drug types target different pathways, so different groups of patients will respond to them, he said: “If I were to look into the future, I envision Kevzara will be approved and show good efficacy in other indications, and the nice thing is many of them will be different.”