What Is Kevzara?
Kevzara, known generically as sarilumab, is an injectable prescription drug approved to treat moderate to severe rheumatoid arthritis (RA). It was approved by the FDA in May 2017.
Kevzara is formulated with a monoclonal antibody designed to bind and block the IL-6 receptor. The IL-6 is believed to play a role in triggering an overactive inflammatory response in the lungs in patients diagnosed with coronavirus, making Kevzara a potentially effective drug in the treatment of COVID-19.
Phase 2/3 Clinical Trials Launched in New York
In March 2020, U.S-based Regeneron Pharmaceuticals and French pharmaceutical giant Sanofi announced their partnership for a clinical program evaluating Kevzara in patients hospitalized with severe COVID-19.
Regeneron and Sanofi began their multi-center, double-blind clinical research study at approximately 16 medical centers in New York. Kevzara was added to the standard regimen of supportive care for coronavirus patients and compared to supportive care plus a placebo in about 400 patients.
In the first part of the Phase 2/3 trial, researchers evaluated the impact of Kevara on fever and patients’ need for supplemental oxygen. During the second, larger part of the trial, researchers plan to evaluate the improvement in longer-term outcomes such as preventing death and reducing the need for mechanical ventilation and supplemental oxygen.
“Scientific evidence has emerged to suggest that Kevzara may be a potentially important treatment option for critically-ill COVID-19 patients, and this trial will provide the well-controlled, rigorous scientific data we need to determine if IL-6 receptor inhibition with Kevzara is better than current supportive care alone,” explained John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi.
Preliminary Clinical Results
At the end of April 2020, Regeneron and Sanofi provided key updates on their Phase 2/3 trial of Kevzara.
The randomized Phase 2 portion of the trial compared IV-administered Kevzara in doses of 400 mg, 200 mg, and placebo. A total of 457 hospitalized patients were assessed, including 28% of patients with severe illness, 49% of patients with critical illness, and 23% of patients with multisystem organ dysfunction. Kevzara appeared to rapidly lower C-reactive protein, a key marker of inflammation.
According to a press release from Regeneron, following the Independent Data Monitoring Committee (IDMC) review of all available Phase 2 and Phase 3 data, “the trial will be immediately amended so that only ‘critical’ patients continue to be enrolled to receive Kevzara 400 mg or placebo.” The less advanced ‘severe’ group and the lower-dose 200 mg Kevzara were both discontinued. As a result, all new patients will be deemed ‘critical’ and receive a 400mg dose of Kevzara or a placebo.
Overall results of the newly refined study are expected sometime in June. At the same time, Regeneron and Sanofi are now enrolling patients in Italy, Spain, Germany, France, Canada, Russia, Israel, and Japan for a second clinical trial outside of the U.S.