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Genentech’s Medicine Receives FDA Emergency Use Authorization For The Treatment Of COVID-19 In Hospitalized Adults And Children

June 24th, 2021

On June 24, 2021, the FDA issued an Emergency Use Authorization (EUA) for intravenous Actemra® (tocilizumab) for the treatment of 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. The EUA is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used under the EUA).


News in brief

  • The EUA is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients.
  • The results of these studies suggest that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.

IMPORTANT INFORMATION ABOUT ACTEMRA FOR COVID-19

AUTHORIZED USE

ACTEMRA is authorized for emergency use under an Emergency Use Authorization (EUA) for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving corticosteroids and who require supplemental oxygen, or a machine that helps with their breathing (ventilator) or a machine that adds oxygen to the blood outside the body (extracorporeal membrane oxygenation or ECMO).

ACTEMRA is not FDA-approved for this use. There is limited information known about the safety or effectiveness of using ACTEMRA to treat people in the hospital with COVID-19. The safety and effectiveness of ACTEMRA have not been studied in pediatric patients hospitalized with COVID-19.

The EUA for ACTEMRA is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the products may no longer be used under the EUA).

IMPORTANT SAFETY INFORMATION ABOUT ACTEMRA FOR COVID-19

ACTEMRA can cause serious side effects. The most important side effects include:

  • Serious infections
  • Tears (perforation) of the stomach or intestines
  • Liver problems (hepatotoxicity)
  • Changes in certain laboratory test results including low neutrophil (white blood cells that help the body fight off bacterial infections) or platelet (blood cells that help with blood clotting and stop bleeding) counts or high liver function tests
  • Allergic reactions: If a patient has symptoms such as rash, swelling of their lips, tongue, or throat, or hives (raised red patches of skin that are often very itchy) they should tell their doctor or nurse. This may mean the patient is having an allergic reaction.
  • Nervous system problems

The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

Patients should not receive ACTEMRA if they are allergic to tocilizumab or if they have had a bad reaction to ACTEMRA previously.

ACTEMRA & pregnancy:

There is limited experience giving ACTEMRA to pregnant women or breastfeeding mothers. ACTEMRA may harm the patient’s unborn baby. It is unknown if ACTEMRA passes into a patient’s breast milk. If a patient is pregnant or breastfeeding, they can discuss their options and specific situation with their doctor.

If a patient is pregnant or becomes pregnant while taking ACTEMRA, they should join the pregnancy registry. To learn more, patients can call the registry at 1-877-311-8972 or talk to their doctor to enroll.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

Please see additional information in Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers, and FDA Letter of Authorization.

For more Important Safety Information please see the full Prescribing Information and Medication Guide, including SERIOUS SIDE EFFECTS.


Levi Garraway, M.D., Ph.D.

“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalizations from severe forms of the disease. We are pleased that Actemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States.”

 

Alexander Hardy, CEO

“Industries, governments and academic institutions have come together to develop solutions to address the enormous challenges of the pandemic. We are proud of the partnerships that we’ve created and the progress we’ve made in conducting scientifically rigorous trials of Actemra in COVID-19. We are committed to collaborating closely with our distribution partners to enable access to Actemra in hospitals across the country to help adults and children with COVID-19, as well as people who depend on the medicine for its FDA-approved indications.”