SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has 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). 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.
“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,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “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.”
“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,” said Alexander Hardy, chief executive officer. “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.”
The four randomized, controlled studies included in the EUA submission investigated the safety and efficacy of Actemra in more than 5,500 hospitalized patients with COVID-19. The RECOVERY Actemra study was led by researchers in the United Kingdom and included more than 4,000 hospitalized COVID-19 patients. Genentech-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies. There have been no new safety signals identified for Actemra in any of these studies. The most common adverse reactions seen (incidence ≥ 3%) are constipation, anxiety, diarrhea, insomnia, hypertension and nausea.
The FDA Letter of Authorization and Fact Sheets for patients and health care professionals are available for download with the latest information on this EUA. For more information on how Genentech is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.
About the Emergency Use Authorization (EUA) for Actemra
Actemra has not been approved by the U.S. FDA in this setting, but the FDA has made Actemra available under an emergency access mechanism called an EUA as a treatment for certain patients with COVID-19. There is limited information known about the safety or effectiveness of using Actemra to treat people in the hospital with COVID-19. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. The authorization is temporary and does not replace the formal review and approval process. Actemra is authorized under the EUA 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. Genentech has existing distribution channels established to ship Actemra to hospitals across the United States.
About the Actemra COVID-19 Clinical Trial Program
Genentech’s clinical trial program evaluated the safety and efficacy of Actemra in hospitalized patients with COVID-19. Actemra is not FDA-approved for this use and there is limited information known about the safety or effectiveness of using Actemra to treat people in the hospital with COVID-19. COVACTA and EMPACTA were the first two global Phase III, multicenter, randomized, placebo-controlled studies of Actemra in patients hospitalized with COVID-19 associated pneumonia. COVACTA was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services (HHS). EMPACTA aimed to address research questions about the safety and efficacy of Actemra in underserved populations by emphasizing enrollment from minority patients often underrepresented in clinical trials. Both studies were published in the New England Journal of Medicine. Genentech also partnered with Gilead Sciences, Inc., on REMDACTA, a Phase III, randomized, double-blind, multicenter study to evaluate the safety and efficacy of Actemra plus Veklury® (remdesivir), versus placebo plus Veklury, in hospitalized patients with severe COVID-19 associated pneumonia.
About Actemra
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. 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. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA), for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), and for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.
Actemra is intended for use under the guidance of a healthcare practitioner.
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.
Important Safety Information for FDA-Approved Indications
Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections.
Actemra can cause other serious side effects. These include:
- Tears of the stomach or intestines
- Liver problems (hepatotoxicity)
- Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels
- An increased risk of certain cancers by changing the way a patient’s immune system works
- Hepatitis B infection
- Serious allergic reactions, including death. These may happen with Actemra infusions or injections, even if they did not occur with an earlier infusion or injection. If a patient has had hives, a rash, or experienced flushing after injecting, the patient should tell their doctor or nurse before their next injection
- Nervous system problems
Patients should not receive Actemra if they are allergic to Actemra or if they have had a bad reaction to Actemra previously.
Most common side effects in patients treated with Actemra:
Patients should tell their doctor if they have these or any other side effect that bothers them or does not go away:
- Upper respiratory tract infections (like common cold and sinus infections)
- Headache
- Increased blood pressure (also called hypertension)
- Injection site reactions
Actemra & pregnancy:
Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. The patient and their doctor should decide if the patient will take Actemra or breastfeed. Patients should not do both. If a patient is pregnant and taking Actemra, they should join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.
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 visit http://www.actemra.com for the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672).
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
