The first patient outside the US has been treated with Kevzara in Sanofi and Regeneron’s global clinical trial programme, which is evaluating the drug in severely ill COVID-19 patients.
Sanofi, which is leading the Kevzara (sarilumab) trials outside the US, announced that the first patient had been dosed today, as the phase 2/3 trial is initiated in Italy, Spain, Germany, France, Canada and Russia.
Earlier this month, Sanofi and Regeneron announced that they had initiated the first trial of Kevzara, which is based in the US. The US has now overtaken both China and Italy in its number of confirmed coronavirus cases, reporting over 140,000 cases as of the 30 March.
The need for effective treatments for the novel coronavirus disease are crucial as global cases surge over 740,000 and deaths climb to more than 34,000.
Kevzara – an interleukin-6 inhibitor – is being evaluated on the basis that IL-6 may play a role in driving the overactive inflammatory response in the lungs of critically and severely ill COVID-19 patients.
This is supported by initial results from a study in China that evaluated another IL-6 inhibitor – Roche’s Actemra (tocilizumab) in severely ill COVID-19 patients.
This small-scale study demonstrated that treatment with the IL-6 inhibitor caused COVID-19 patients to experience rapidly reduced fevers, and 75% of patients reduced their need for supplemental oxygen within days of receiving the drug.
As a result of this preliminary data, Roche won an approval in China for Actemra as a treatment for patients with severe or critical COVID-19.
“Sanofi and Regeneron are relentlessly working to rapidly initiate trials around the world that will help determine whether Kevzara has the potential to play a role in addressing the COVID-19 global health crisis,” said John Reed, global head of research and development at Sanofi.
“These trials will provide important data to determine whether Kevzara ameliorates the life-threatening complications of COVID-19 infections by counteracting the overactive inflammatory responses in the lungs when damaged by the virus,” he added.
Last week, the US Food and Drug Administration (FDA) approved US-based trial of Roche’s Actemra following its promising results in China.
Both Roche and Sanofi/Regeneron’s drugs are already approved for the treatment of rheumatoid arthritis, but have been repurposed after their potential against COVID-19 was first discovered earlier this month.