Late-Stage Study Combines an Antiviral with Immune Modulator For Treating COVID-19 Patients
Roche announced the initiation of a global phase III study to evaluate the safety and efficacy of Actemra/RoActemra, plus the investigational antiviral Remdesivir, in treating hospitalized patients with severe COVID-19 pneumonia.
Actemra/RoActemra is approved in more than 110 countries worldwide for the treatment of moderate-to-severe active rheumatoid arthritis (RA), and other indications.
Remdesivir has been issued an Emergency Use Authorisation by the US Food & Drug Administration (FDA) for the treatment of hospitalized patients with severe COVID-19.
In collaboration with Gilead Sciences, Inc., this randomized, double-blind, multicentre study (REMDACTA) is expected to begin enrolling in June 2020, with a target of approximately 450 patients globally.
The primary and secondary study endpoints include clinical status, mortality, mechanical ventilation, and intensive care variables. Patients will be followed for 60 days post-randomization.
“As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, in a press statement.
"Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe (COVID-19) disease.”
And, Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA).
Actemra/RoActemra can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs).
In Europe, RoActemra IV and SC are also approved for use in adult patients with severe, active, and progressive RA, who previously have not been treated with MTX.
Actemra/RoActemra IV and SC are approved globally for polyarticular juvenile idiopathic arthritis (pJIA) and in the US and Europe for systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older.
Actemra/RoActemra SC injection is also the first approved therapy for the treatment of giant cell arteritis (GCA) in more than 40 countries, including the US and Europe.
In the US and Europe, Actemra/RoActemra IV injection is approved for the treatment of chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome (CRS) in people two years of age and older.
Actemra/RoActemra was the first approved treatment for CRS in this setting. A prefilled autoinjector ACTPen has been approved in the US and Europe.
In Japan, Actemra is also approved for the treatment of Castleman’s Disease, adult Still's disease, and Takayasu Arteritis.
Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005.
For more information, please visit Roche.
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