Last Updated on December 31, 2023 by The Health Master
The US health regulators have approved Roche’s arthritis drug Actemra for emergency use to treat hospitalised C-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.
The US Food and Drug Administration (USFDA) said yesterday that it had issued an emergency use authorisation (EUA) for Actemra to treat adults and pediatric patients hospitalised with C-19.
For months already, the medicine has been given to severely ill C-19 patients on a compassionate-use basis, generating hundreds of millions in sales for Roche.
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 USFDA said, adding studies showed Actemra helped reduce the risk of death.
The EUA is based on results from four randomised, controlled studies that evaluated Actemra for the treatment of C-19 in more than 5,500 hospitalised patients, Roche said.
In the first quarter, Actemra sales rose 22 per cent to 779 million Swiss francs ($850 million), after surging nearly a third to 2.9 billion francs in 2020, mostly due to treatment of patients with severe C-19-associated pneumonia.
Though rising vaccinations in places such as Europe and the United States are reducing hospitalisations for C-19, Actemra is still being deployed for certain patients who land in the hospital.
“Even with the availability of vaccines and declines in deaths from C-19 in various parts of the world, we continue to see new hospitalisations from severe forms of the disease,” said Levi Garraway, Chief Medical Officer (CMO), Roche.
Testing Actemra for C-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 C-19 or as a treatment for C-19, the health agency said.
Last year, the FDA approved Gilead Sciences Inc’s anti-viral drug Remdesivir for treating patients hospitalised with C-19, but a trial mixing Actemra with Remdesivir failed to cut hospital stays.
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