- Source : Press Release
- Date : 2020-08-05
- Event type : Phase 3
- Companies : Merck KGaA
Merck Statement on Rebif (Interferon Beta-1a) Contribution to the US National Institute of Allergy and Infectious Diseases for the ACTT 3 Trial
As part of the global effort to investigate potential COVID-19 therapeutics and our support of independent research, Merck is collaborating with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) by contributing 3,000 units of Rebif® (subcutaneous interferon beta-1a) for the Adaptive COVID-19 Treatment Trial 3 (ACTT 3), which is enrolling hospitalized adults with COVID-19 in the United States and in other countries. The NIAID-led study is evaluating treatment with Rebif® in combination with remdesivir compared with remdesivir alone, in over 1,000 hospitalized adults diagnosed with COVID-19 and will evaluate time to recovery in the combination therapy group relative to the remdesivir-only group.
This contribution complements our previously announced donation of up to 300,000 units of Rebif® to the international trials sponsored by the French INSERM institute (Institut National de la Santé et de la Recherche Médicale) and the World Health Organization (DisCoVery and SOLIDARITY).
Rebif® is indicated for the treatment of relapsing forms of multiple sclerosis (MS). To date, Rebif® is not approved by any regulatory authority for the treatment of COVID-19 or for use as an antiviral agent.
As a company dedicated to human progress and to making a lasting difference on patients’ lives Merck is fully committed to contributing to solutions related to global health crises such as COVID-19. We continue to work closely with health authorities to respond to the needs of patients impacted by COVID-19.
For additional information on this trial please visit https://www.niaid.nih.gov/news-events/nih-clinical-trial-testing-remdesivir-plus-interferon-beta-1a-covid-19-treatment-begins.
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About Rebif® (interferon beta-1a)
Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif® in chronic progressive MS has not been established. The exact mechanism is unknown.
Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide.
Rebif® can be administered with the RebiSmart® electronic auto-injection device (not approved in the US), or with the RebiDose® single-use disposable pen, or the manual multidose injection pen RebiSlide™. Rebif® can also be administered with the autoinjector Rebiject II® or by manual injection using ready-to-use pre-filled syringes. These injection devices are not approved in all countries.
In January 2012, the European commission approved the extension of the indication of Rebif® in early multiple sclerosis.
Rebif® should be used with caution in patients with a history of depression, liver disease, thyroid abnormalities and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.