Actemra (Tocilizumab) Description
Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. Actemra is an Interleukin-6 (IL-6) receptor antagonist approved by the FDA in 2010.
The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries.
Additionally, to further support U.S. COVID-19 response efforts, Genentech announced it would 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.
Actemra (Tocilizumab) Indication
Actemra is currently approved for indications in rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. Actemra® (tocilizumab) 400 mg/20 mL vial for intravenous use.
Actemra is also in clinical studies to assess if Actemra is an effective treatment for adults with severe COVID-19 disease. In some patients with COVID-19, however, the immune response runs amok, overexpressing IL-6 and generating a “cytokine storm,” which can lead to potentially life-threatening damage to lungs and other organs.
At present, there is very limited evidence on the safety or efficacy of Actemra in the clinical treatment of COVID-19, and Actemra is not currently FDA-approved for this use.
Actemra COVID-19 Clinical Trials
Clinical Trial NCT04320615: A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA). The randomized, double-blind, placebo-controlled trial, will evaluate the safety and efficacy of intravenous Actemra plus standard of care in hospitalized adults with severe COVID-19 pneumonia, compared to placebo plus standard of care.
Actemra (Tocilizumab) News
April 29, 2020 - Chinese researchers published a study in PNAS concluding from preliminary data that Actemra improved clinical outcomes immediately in 20 patients with severe or critical COVID-19, and thus “is an effective treatment to reduce mortality.” Five days after treatment, 15 of the 20 patients (75%) lowered their oxygen intake, and 1 patient needed no oxygen therapy.
April 29, 2020 - UC San Diego Health has launched a Phase III clinical trial, part of a global effort, to assess whether a medication used to treat rheumatoid arthritis and other inflammatory disorders might also have therapeutic value for COVID-19 patients who have developed or at high risk of developing serious lung damage from SARS-CoV-2 infections.
March 19, 2020 - Genentech, a Member of the Roche Group, announced it is launching a Phase III trial to assess its marketed arthritis drug Actemra® (tocilizumab) as a treatment for adults with severe COVID-19.