In the fight against the coronavirus, Roche has just obtained a precious green light from the FDA. The US Medicines Agency has approved the marketing of the drug tocilizumab, sold under the name Actemra, to treat Covid-19 in hospitalized adults, the pharmaceutical group announced on Wednesday.
Since the start of the pandemic, this drug initially intended for the treatment of rheumatoid arthritis has been used to treat more than a million people hospitalized for Covid-19 infection worldwide. It is also approved for this use in more than 30 countries.
One taken intravenously
In the United States, this monoclonal antibody administered intravenously had been used on the basis of an emergency authorization granted in June 2021. In early April, Roche announced that its application for approval in the United States for the use of its drug for hospitalized Covid-19 patients was going to be given priority review, a status that is reserved for drugs for serious conditions for which there are few treatment options.
The FDA has approved the drug’s use “intravenously (IV) for the treatment of Covid-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygenation, noninvasive or invasive mechanical ventilation, or oxygenation by extracorporeal membrane. Roche further clarified that the drug is recommended for use as a single 60-minute intravenous infusion.
“With the emergence of new variants, FDA-approved treatments, including Actemra, remain essential to the continued fight against Covid-19,” said the medical director and head of product development of the Swiss pharmaceutical giant, Levi Garraway. “Actemra is the first FDA-approved monoclonal antibody to treat patients with severe Covid-19,” he added.
The Swiss group had filed its application for approval on the basis of four studies carried out with more than 5,500 hospitalized patients. The World Health Organization had also prequalified last February tocilizumab to treat patients with severe forms of Covid-19.