Covid-19: Roche obtains the approval of the drug Actemra
The American Medicines Agency (FDA) has authorized a new drug to treat Covid-19.
THE boss of the American Medicines Agency (FDA) Janet Woodcock.
The US Medicines Agency (FDA) has given the green light for the marketing of the drug tocilizumab – sold under the name Actemra – to treat Covid-19 in hospitalized adults, the pharmaceutical group Roche announced on Wednesday.
Since the start of the pandemic, this drug originally intended for the treatment of rheumatoid arthritis has been used to treat more than one million people hospitalized with Covid-19 infection globally, and is approved for this use in more than 30 countries, the group said in a press release. 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 in patients hospitalized with Covid was going to be the subject of a priority review, a status which is reserved for drugs intended for diseases. severe conditions for which there are few treatment options.
A single 60-minute infusion
The FDA has approved the drug for 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”, explains the press release from Roche. The Swiss group specifies 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, in the press release. “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 (WHO) pre-qualified tocilizumab last February to treat patients with severe forms of Covid-19.
AFP
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