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FDA approves new Covid treatment for hospitalised adults

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Genentech has announced than the FDA has approved Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalised adults.

The approval applies to patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Actemra is the first FDA-approved monoclonal antibody to treat Covid and is recommended for use as a single 60-minute IV infusion.

Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, said:

“With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19.

“Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalised patients and their healthcare providers who continue to be on the frontlines treating COVID-19.”

Four randomised, controlled studies evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients.

Altogether, the results of the four studies showed that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.

The FDA approval is based on the results from the RECOVERY trial, as well as the EMPACTA trial, which was the first global, Phase III study in COVID-19 to focus on patients from underrepresented racial and ethnic groups.

The most common adverse reactions seen (incidence ≥ 3 per cent) are constipation, urinary tract infection, hypertension, anxiety, diarrhoea, insomnia and nausea.

The FDA approval follows the FDA’s Emergency Use Authorization (EUA) for Actemra in hospitalised adults and children ages 2 and above with COVID-19, which was granted in June 2021.

More than one million people hospitalised with COVID-19 have been treated with Actemra worldwide since the beginning of the pandemic.

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