Kolkata: Amid the outbreak of novel coronavirus across the world, Roche Pharma division, one of the world’s largest biotech company, has initiated clinical trial of medicine ‘Actemra’ or ‘RoActemra’ to explore its potential use in treatment of severe COVID-19 pneumonia patients.
While the ongoing trial of ‘Actemra’ is underway, Roche has also clarified that if any physician is prescribing this off-label medicine, “they do so with greater degree of uncertainty associated with its use.”
While responding to News18 questionnaires on Roche’s stand on fighting against the coronavirus, a spokesperson of the company, said, “We have initiated 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 (ASPR) to explore its potential use in treatment of severe COVID-19 pneumonia patients.”
“This is the first global study of Actemra/RoActemra in this setting. In addition to this 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,” he said.
On the context of off-label use of this medicine by physician, he said, “Given the lack of approved treatment options, we understand that there may be off-label use of products approved for other use. Roche respects the freedom of prescription and we believe that when a physician chooses to prescribe a medicine, approved or otherwise, they should do so because they believe it is the most appropriate medicine for an individual patient, taking into account relevant national laws and regulations.”
“Also, when they are prescribing an off-label medicine, they do so with the knowledge that the product has not gone through the stringent regulatory process for the specific disease in question, and that as such there is a greater degree of uncertainty associated with its use,” he said.
On current status of coronavirus test kits, he said, “We have received conditional import license from the Central Drugs Standard Control Organisation (CDSCO) for the cobas SARS CoV-2 diagnostic test, and we have initiated the process of importing these test kits. The cobas SARS CoV-2 test is likely to be made available for patient testing in India over the next few weeks.”
When inquired about vaccines and treatment options of coronavirus, Roche has clarified that they are not in the vaccines space and only clinical trial of ‘Actemra’ is underway.
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“We are is engaged in active dialogue with several State Governments and Union Government organisations to enable access to the cobas SARS CoV-2 test to patients in India,” he said on being asked about Public-Private Partnership (PPP).
Recently, Roche Diagnostics has received green signal from the central government to carry COVID-19 test in India. Roche Diagnostics India got the approval from Central Drugs Standard Control Organisation (CDSCO), which comes under Union Ministry of Health and Family Welfare.