Friday, 19 April, 2024
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FDA approves arthritis drug for emergency use in hospitalised COVID patients

The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for Roche's Actemra, an arthritis medicine, to treat adults and paediatric patients hospitalised with COVID-19. This will give an extra boost to a medicine that was already allowed to be administered on compassionate grounds, reports Reuters.

The FDA last week issued an emergency use authorisation (EUA) for Actemra to treat adults and paediatric patients hospitalised with COVID-19.

For months already, the medicine has been given to severely ill COVID-19 patients on a compassionate-use basis.

The drug can be used to treat patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation, the FDA said, adding that studies have showed Actemra helps reduce risk of death and speed recovery.

The EUA is based on results from four randomised, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalised patients, Roche said.

Though rising vaccinations in places such as Europe and the United States are reducing hospitalisations for COVID-19, Actemra is still being deployed for certain patients who end up in hospital.

“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalisations from severe forms of the disease,” said Levi Garraway, the company's chief medical officer.

Testing Actemra for COVID-19 patients involved trial and error, as successes in studies underpinning the FDA's EUA were accompanied by several failures in different patient groups as the Swiss company gathered knowledge about just who would benefit.

Actemra is not authorised for use in outpatients with COVID-19 or as a treatment for COVID-19, the health agency said.

Last year, the FDA approved Gilead Sciences Inc's (GILD.O) antiviral drug remdesivir for treating patients hospitalised with COVID-19, but a trial mixing Actemra with remdesivir failed to cut hospital stays.


Reuters story US approves Roche drug for emergency use against severe COVID-19 (Open Access)


See also from MedicalBrief archives:


China gives green light for Actemra to treat COVID-19 patients with lung disease


Repurposed hep C drugs plus remdesivir highly effective at inhibiting SARS-Cov-2 — In vitro study


Arthritis drug effective in most severely ill COVID-19 patients



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