Genentech’s Actemra gets FDA approval to begin COVID-19 Trials in April

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

While we are still waiting on the clinical trial data of Gilead’s remdesivir, Genentech bags approval from the FDA to test Actemra (tocilizumab) in adult patients with severe COVID-19 pneumonia. Actemra is Roche’s blockbuster drug that got FDA approval a decade ago to treat Rheumatoid arthritis. Genentech, a member of the Roche group announced that it will test the drug in a double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate its safety and efficacy combined with standard of care in adult patients with severe COVID-19 pneumonia.

Earlier this month, at a government press conference, the Chinese Academy of Sciences announced promising results for a list of repurposed drugs including Actemra in 14 serious and critically ill patients being treated at a hospital affiliated with the University of Science and Technology of China (USCT). The positive effects of the drug in a handful of patients made China’s National Health Commission update its treatment guidelines to include Actemra as a treatment for serious coronavirus patients with lung damage.

Supporting the COVID-10 response efforts, Genentech has also promised to deposit a big stock of 10,000 vials of the drug to the U.S. Strategic National Stockpile for potential future use. To make sure that the demand for the drug is fulfilled as and when needed, Genentech is also working with distributors to manage continuous product supply.


Actemra Targets the Cytokine Storm

Both rheumatoid arthritis and COVID-19 have one thing in common, the cytokine storm. In both these diseases, the internal tissue structure is destroyed by an extensive release of cytokines- meant to kill the infectious agent-by body’s immune system. Actemra is a humanized interleukin-6 receptor antagonist that is hypothesized to reduce SARS-CoV-2 led inflammation in the lungs by its anti-inflammatory action. The drug’s anti-inflammatory action has been so successful that it gained the FDA approval for treating severe or life-threatening cytokine release syndrome in leukemia or lymphoma patients undergoing CAR T therapy in 2017. In Genentech’s phase III trial that begins in April, actemra will be intravenously administered in 330 COVID-19 patients worldwide and the patients will be monitored for 60 days to determine primary and secondary endpoints of clinical status, mortality, mechanical ventilation, and intensive care unit variables.


Ongoing Actemra Trials Worldwide

Roche’s Actemra and Regeneron’s Kevzara are the only two IL-6 receptor antagonists currently under trial for COVID-19 treatments. The drug alone or in combination with other drugs is being tested in four clinical trials in China and Italy, two of the most affected countries. The list of trials according to the Chinese Clinical Trials Registry, Italian Medicines Agency and NIH clinical trials are provided below:

  1. A trial led by Hong Zhao of Peking University First Hospital, enrolled 150 patients to access the efficacy of Actemra in combination with Favipiravir, a broad-spectrum antiviral agent sold by Zhejiang Hisun Pharmaceutical in China and by Fujifilm in the U.S.
  2. A trial with 188 patients led by Dongsheng Wang of the First Affiliated Hospital of the University of science and technology of China is assessing Actemra’s efficacy alone against SARS-CoV-2.
  3. Led by researchers at Universita Politecnica Delle Marche and Azienda Ospedaliera Ospedali Riuniti Marche Nord, this 30 patient Phase II trial is assessing Actemra alone in patients affected by severe pneumonia correlated to SARS-CoV-2.
  4. TOCIVID-19 study led by the National Institute for the study and treatment of cancer in Naples with the University of Modena and Reggio Emilia and the IRCCS of Reggio Emilia is going to evaluate the efficacy and safety of Actemra alone in the treatment of Pneumonia associated with COVID-19.

Although several independent trials are ongoing, none of the trials have yielded solid evidence on the safety or efficacy of the drug in COVID-19 patients. This FDA approved trial is particularly important because it will build robust evidence in a placebo-controlled manner for Actemra as a COVID-19 treatment.

“We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from pneumonia following coronavirus infection and we’re moving forward to enroll as quickly as possible,” said Alexander Hardy, chief executive officer of Genentech. “Conducting this clinical trial in partnership with BARDA and providing Actemra to support the national stockpile, through the efforts of Secretary Azar and HHS, are important examples of how the U.S. government the biotechnology industry and healthcare communities are working together in response to this public health crisis.”

Related Article: Gilead’s Remdesivir Wins FDA’s Orphan Drug Designation for COVID-19 Treatment



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