Genentech Initiates Phase III Clinical Trial of Actemra in Hospitalized Patients With Severe COVID-19 Pneumonia
This is the first global study of Actemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including
"We are initiating a clinical trial to study Actemra for the treatment of people hospitalized with COVID-19 pneumonia, so that we can better establish the potential role for Actemra in fighting this disease," said
To date, there are several independent clinical trials exploring the efficacy and safety of Actemra for the treatment of patients with COVID-19 pneumonia. Actemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s
However, this new trial is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra in the treatment of patients suffering from COVID-19. In addition, Actemra is not currently approved for this use by any health authorities, including the FDA.
In addition to initiating this trial,
For more information on how
About the Clinical Trial
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) and for patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA). 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 Safety Information
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)
- 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 http://www.FDA.gov/medwatch. Report side effects to
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).
Actemra is part of a co-development agreement with
Founded more than 40 years ago,
Shirley Dang (650) 467-6800
Jennifer Fenoglio (650) 207-8161
Lisa Tuomi (650) 467-8737
Karl Mahler +41 61 687 8503