Switzerland: Global Pandemic Roche Begins Global Phase III Study of Actemra Drug for Covid-19 Patients
Roche has collaborated with the Biomedical Advanced Research and Development Authority to kick-start the vital study which is expected to evaluate the safety of the Actemra drug for adult patients with severe Covid-19 pneumonia. The company has also introduced testing solutions to detect the virus.
Basel/Switzerland – Roche Group has recently provided an update on the various actions the company is taking to address the Covid-19 pandemic.
Roche Initiates Global Phase III Study and Collects Data on Actemra’s Potential Utility in Severe Covid-19 Pneumonia Patients
On March 19, 2020, Roche confirmed initiation of a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (Barda), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response. The study, Covacta, will evaluate the safety and efficacy of intravenous Actemra/Roactemra (tocilizumab) on top of standard of care in hospitalised adult patients with severe Covid-19 pneumonia compared to placebo on top of standard of care.
This is the first global study of Actemra/Roactemra in this setting. In addition to the Roche trial, Roche is also carefully following independently-led clinical trials, on multiple medicines including Actemra, that are taking place around the world.
At the moment, there are no robust, well-controlled studies showing safety and efficacy of Actemra in clinical treatment of Covid-19 pneumonia, and Actemra is not currently approved for this use.
Actemra Manufacturing and Supply
Despite some of the supply and logistics challenges due to Covid-19, the company has been able to continue to deliver life-saving medicines to patients around the world, thanks to the resilience of its global network. Currently, the firm is continuing to see limited disruption, and is continually monitoring the situation.
With the announcement of new clinical trials, and a potential increase in demand for Actemra, the company is working urgently to accelerate manufacturing capacity in order to maximise production of Actemra wherever possible with the goal of increasing the available supply globally.
While the company is ensuring a coordinated, global overview of additional supply requests, provision of medicines is managed on a country level according to local rules and regulations and in close collaboration with the authorities.
Cobas Sars-Cov-2 Test to Detect the Novel Virus that Causes Covid-19 Disease
As one of the leaders in diagnostics, the firm is committed to providing testing solutions for the world’s most challenging healthcare emergencies. On March 12, 2020, Roche received FDA Emergency Use Authorisation for the Cobas Sars-Cov-2 Test to detect the novel virus that causes the Covid-19 disease. The test is also available in markets accepting the CE mark.
The firm is committed to delivering as many tests as possible within the limits of supply and delivering its coronavirus tests to areas where they can be immediately effective. Tests will be shipped from Roche’s production sites to locations where appropriate infrastructure is in place and testing can begin without delay.
At the current maximum production rate, the company can supply millions of tests per month on the cobas 6800/8800 instruments and on the Magnapure / Lightcycler solution. Roche is working around the clock to increase that quantity as the company recognises the importance of patients having access to these critical tests.
To safeguard supply, the firm strongly advises to focus Covid-19 testing on patients with signs and symptoms of the disease, not broad testing of the healthy population.