An EUA is a US Food and Drug Administration (FDA) authorization for the emergency use of an unapproved product or unapproved use of an approved product (ie, drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that there is a public health emergency that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include 1:
The EUA process differs from the FDA-approval process in that an EUA makes a product available for use in an emergency based on the best currently available data, without waiting for the additional evidence that would be required for an FDA approval. EUAs are in place for the duration of the declaration that circumstances exist justifying the authorization of the emergency use. They may be revised or revoked as the FDA continues to evaluate patient needs and the data available. 1,2
Under the EUA, ACTEMRA is authorized for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). However, ACTEMRA is not FDA-approved for this use.
ACTEMRA is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ACTEMRA under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. See the full Fact Sheet for Healthcare Professionals for the justification for emergency use of drugs during the COVID-19 pandemic, information on available alternatives, and additional information on COVID-19. 1
The adverse reaction rates observed in the clinical studies of ACTEMRA used to support this EUA cannot be directly compared to rates in the clinical studies of ACTEMRA for FDA-approved indications and may not reflect the rates observed in clinical practice.
The safety evaluation of ACTEMRA in COVID-19 was based on 4 clinical trials. These included one randomized, controlled, open-label, platform trial [Randomised Evaluation of COVID-19 Therapy (RECOVERY)] and 3 randomized, double-blind, placebo controlled trials (EMPACTA, COVACTA, and REMDACTA). For more information on the safety findings from the EUA clinical trials, please see the Safety Data page and the Fact Sheet for Healthcare Professionals . 1
ACTEMRA subcutaneous (SC) administration is not authorized for the treatment of COVID-19 patients. 1
The prescribing healthcare provider and/or the provider’s designee are/is responsible for mandatory reporting of all serious adverse events* and medication errors potentially related to ACTEMRA within 7 calendar days from the onset of the event, using FDA Form 3500 (for information on how to access this form, see below). The FDA recommends that such reports, using FDA Form 3500, include the following 1:
Submit adverse event and medication error reports, using Form 3500, to FDA MedWatch using one of the following methods 1:
The prescribing health care provider and/or the provider’s designee is/are to provide mandatory responses to requests from FDA for information about adverse events and medication errors associated with ACTEMRA. 1
*Serious adverse events are defined as:
For more information about the clinical profile for ACTEMRA in COVID-19, please contact your local Medical Service Liaison. Additionally, you may contact Genentech Medical Affairs or call 1-800-821-8590.
ACTPen is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
Fact Sheet for Healthcare Providers: Emergency Use Authorization (EUA) for ACTEMRA® (tocilizumab). South San Francisco, CA: Genentech, Inc; June 24, 2021.
Fact Sheet for Healthcare Providers: Emergency Use Authorization (EUA) for ACTEMRA® (tocilizumab). South San Francisco, CA: Genentech, Inc; June 24, 2021.
FDA.gov. Understanding the regulatory terminology of potential preventions and treatments for COVDI-19. Accessed May 4, 2021. https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19
FDA.gov. Understanding the regulatory terminology of potential preventions and treatments for COVDI-19. Accessed May 4, 2021. https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19
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