Our Commitment to Providing Ongoing ACTEMRA Information During the COVID-19 Pandemic
Genentech takes the health and safety of patients very seriously. This website is intended to provide information on ACTEMRA during the COVID-19 outbreak to enable physicians to make patient treatment decisions.
ACTEMRA is not FDA-approved for use in severe COVID-19
ACTEMRA is a monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin-6 (IL-6) is a cytokine that plays an important role in immune responses.
Genentech, a member of the Roche group, initiated three Phase 3 and one Phase 2 clinical trials to evaluate ACTEMRA in COVID-19 associated pneumonia. Information on these trials may be found in the “COVID-19 Clinical Trials” section of this website or by accessing www.clinicaltrials.gov.
UPDATE: On July 28, Genentech announced that the Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter COVACTA study did not meet its primary endpoint of showing improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia. The study also failed to meet key secondary endpoints, including reduced patient mortality.
UPDATE: On September 17, Genentech announced that the Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter EMPACTA study met its primary endpoint showing that the cumulative proportion of hospitalized COVID-19 pneumonia patients who progressed to mechanical ventilation or death by day 28 was less in Actemra-treated patients compared to placebo. The study did not meet key secondary endpoints, including improvement in patient mortality. No new safety signals for Actemra were identified.
This website is intended to make available, in a transparent manner, the information we have on the use of ACTEMRA for COVID-19 pneumonia to enable physicians to make informed individual patient treatment decisions. The ultimate decision to use ACTEMRA for COVID-19 pneumonia patients remains with the treating physician.
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COVID-19 Clinical Trials
Roche-Sponsored Clinical Trials in COVID-19
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ACTEMRA is indicated for the treatment of:
- Adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
- Adult patients with giant cell arteritis (GCA)
- Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) in patients
- Patients 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA)
- Adults and pediatric patients 2 years of age and older with chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome.
Important Safety Information
Boxed Warning: Risk of Serious Infections
Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving ACTEMRA. If a serious infection develops, interrupt ACTEMRA until the infection is controlled. Perform test for latent TB; if positive, start treatment for TB prior to starting ACTEMRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
Apr 2020 - Shipping short-dated ACTEMRA (tocilizumab) 400 mg/20 mL vial for IV with dark blue cap