The blockbuster rheumatoid arthritis field has a new contender.
On Monday, the U.S. FDA gave the green light to Regeneron and Sanofi Genzyme’s investigational monoclonal antibody Kevzara (sarilumab).
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The two companies first filed the BLA in October 2016. However, that application was rejected with a complete response letter (CRL) calling out “manufacturing deficiencies.” Today’s news puts that to rest.
Per the label, Kevzara is indicated for adult patients with moderate to severe, active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). It works by targeting interleukin-6 receptors (IL-6Rs), thereby inhibiting a key source of inflammatory signaling.
In a joint company statement, Alan Kivitz, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center and a study investigator, said the unique mechanism of action will be critical for patients that don’t respond to existing therapies.
“This is important because not all currently available treatments work in all patients, and some patients may spend years cycling through different treatments without achieving their treatment goals,” Kivitz said. “Sarilumab works differently from the most commonly used biologics, such as those in the anti-TNF class, and is a welcome new option for patients and their physicians.”
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Those anti-TNF drugs include household names such as Enbrel, Remicade, and Humira. While these drugs have revolutionized the field — and generated billions in revenue —around 20-40 percent of patients treated with this class of drugs don’t achieve a significant reduction in symptoms. As a result, Kevzara could commandeer a unique foothold in the market.
On the other hand, early sales projections have been low. As a recent GlobalData survey showed, rheumatologists tend to favor what they know. Enbrel was first approved in 1998. Humira launched in 2003. That’s a lot of history for doctors and patients.
Regeneron and Sanofi have at least trick up their sleeve, which early market projections couldn’t account for. In today’s announcement, the two companies revealed a list price around 30 percent less than Humira and Enbrel, which were at one point the top two best-selling drugs on the market.
“The U.S. Wholesale Acquisition Cost (WAC) of Kevzara is $39,000/year for the 200 mg and 150 mg doses,” the statement read, noting that it is approximately 30 percent cheaper than the two most widely used TNF-alpha inhibitors (Humira and Enbrel). With discounts, rebates and copay support, many payers and insurers will pay even less.
It’s a smart move to win over patients. Once an effective therapy is found, they’re unlikely to switch. Unlike oncology biologics, RA patients can take these therapies for decades.
It has been a stellar start to the year for the Sanofi-Regeneron partnership, following the late-March approval of Dupixent for atopic dermatitis (eczema). Dupixent was fast out of the gates, with as many as one-third of dermatologists writing a prescription within 30 days of its launch. The companies will no doubt be hoping for a repeat when Kevzara rolls out.
Photo: Waldemarus, Getty Images
