Sanofi Begins Kevzara Study for Severe Coronavirus Infection

Sanofi SNY 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 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 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] 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.

The Hottest Tech Mega-Trend of All

Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.

See Zacks' 3 Best Stocks to Play This Trend >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
 
Sanofi (SNY) : Free Stock Analysis Report
 
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
 
Bristol-Myers Squibb Company (BMY) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research