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Roche Gets FDA Approval for Actemra Trials in COVID-19

Zacks Equity Research

Roche RHHBY announced that the FDA has approved a randomized, double-blind, placebo-controlled phase III study to evaluate the safety and efficacy of intravenous rheumatoid arthritis (RA) drug, Actemra (tocilizumab), plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.

The study will be conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).

The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days, post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy.

Moreover, Genentech will provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services (HHS).

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Earlier, Roche received an FDA Emergency Use Authorisation for the cobas SARS-CoV-2 Test to detect the novel virus that causes the COVID-19 disease.
Several independent clinical studies are ongoing worldwide to explore the efficacy and safety of Actemra for the treatment of patients with COVID-19 pneumonia. However, this new study is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra in the treatment of patients suffering from COVID-19.

Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs or pipeline candidates are being tested to see if they are effective in treating the infected patients.

Per the recent results published in The New England Journal of Medicine, AbbVie’s ABBV HIV drug, Kaletra, failed to show any benefit over standard care in adult patients with severe COVID-19 in China. The results came as a disappointment, given the urgent need for treating infected patients.

Roche’s stock has gained 4.2% in the past year against the industry’s 18.4% decline.

 

President Trump reportedly wants to speed up the approval of vaccines and treatments to fight the pandemic.

Regeneron REGN and partner Sanofi have also announced a program to evaluate their rheumatoid arthritis drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19.

Meanwhile, the FDA is also working with government agencies and academic centers, which are evaluating the use of chloroquine to treat patients with mild-to-moderate COVID-19 infection to potentially reduce the duration of symptoms, as well as viral shedding, and help prevent the spread of the disease.

Chloroquine is already approved for treating malaria, lupus and rheumatoid arthritis. Studies are underway to determine the efficacy of using chloroquine to treat COVID-19.

Meanwhile, Gilead Sciences, Inc. GILD has initiated two phase III studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19. The candidate was previously under testing for the Ebola virus.

Desperate times call for desperate measures and pharma/biotech companies are running a race against time to successfully develop treatments and vaccines to combat this contagious disease. While the drugs and vaccines will need some time to be tested and a cure is not imminent, investors will keep an eye on these companies as the pandemic is not likely to die out soon.

Roche 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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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
 
Roche Holding AG (RHHBY) : Free Stock Analysis Report
 
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
 
AbbVie Inc. (ABBV) : Free Stock Analysis Report
 
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