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Sanofi Begins Kevzara Study for Severe Coronavirus Infection

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Sanofi (SNY - Free Report) announced that it has treated the first patient with Kevzara (sarilumab) among the hospitalized patients with severe COVID-19 infection outside the United States. The second double-blind phase II/III study was recently initiated in Italy, Spain, Germany, France, Canada, Russia as part of the Kevzara COVID-19 program.

The study is enrolling patients immediately outside the United States and will assess the safety and efficacy of adding a single intravenous dose of Kevzara to usual supportive care versus supportive care plus placebo.

Shares of Sanofi have lost 4.2% in the past year compared with the industry’s decrease of 9.3%.

Earlier this month, Regeneron Pharmaceuticals, Inc.  (REGN - Free Report) and Sanofi announced a program to study their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to the coronavirus disease, COVID-19.

While Regeneron is conducting studies in the United States, Sanofi is responsible for the same outside the country.

Kevzara is an anti-interleukin (IL)-6 receptor monoclonal antibody. In patients who are severely or critically ill with COVID-19, the IL-6 pathway may play an important role in driving the overactive inflammatory response in the lungs, per the press release.

Per the press release, in a Chinese study, it was observed that another IL-6 receptor antibody (tocilizumab) led to rapidly-reduced fevers in critically ill COVID-19 patients. Moreover, 75% of patients showed reduced r need for supplemental oxygen within days of being treated with the medicine.

So, both Regeneron and Sanofi believe that Kevzara due to its IL-6 receptor inhibition, may emerge as a treatment option for critically-ill COVID-19 patients.

Several drug/biotech companies are now working on making new antibodies, drugs and vaccines to prevent and treat the deadly COVID-19. Gilead’s (GILD - Free Report) investigational antiviral candidate, remdesivir, is being evaluated in two phase III studies to treat COVID-19.

Meanwhile, in a separate press release, Sanofi announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending marketing authorization to Sarclisa (isatuximab) combination therapy for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) in the third-line setting.

The company is seeking approval of Sarclisa in combination with Celgene’s [now part of Bristol-Myers (BMY - Free Report) ] Pomalyst (pomalidomide) and dexamethasone (pom-dex) for treating adult patients with RRMM who already received at least two prior therapies including Revlimid (lenalidomide) and a proteasome inhibitor and also demonstrated disease progression on the last therapy.

The CHMP’s opinion will be now reviewed by the European Commission with a decision expected in the coming months.

Earlier this month, the FDA granted approval to Sarclisa (isatuximab-irfc) in combination with Pomalyst and dexamethasone for treating adults with RRMM, having received a minimum of two prior therapies including Revlimid (lenalidomide) and a proteasome inhibitor.

Zacks Rank

Sanofi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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