Roche Gets FDA Approval For Actemra Trials In COVID-19
Zacks Investment Research | Mar 23, 2020 09:33PM ET
Roche (OTC: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).
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 (NYSE: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 Zacks Investment Research
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