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 The U.S. Food and Drug Administration (FDA) said on Thursday it had
issued an emergency use authorization (EUA) for Actemra to treat
adults and pediatric patients hospitalized with COVID-19.
For months already, the medicine has been given to severely ill
COVID-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 FDA said, adding studies showed Actemra helped
reduce risk of death and speed recovery.
The EUA is based on results from four randomized, controlled studies
that evaluated Actemra for the treatment of COVID-19 in more than
5,500 hospitalized patients, Roche said.
In the first quarter, Actemra sales rose 22% 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
COVID-19-associated pneumonia.
Though rising vaccinations in places such as Europe and the United
States are reducing hospitalizations for COVID-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
COVID-19 in various parts of the world, we continue to see new
hospitalizations from severe forms of the disease,” said Levi
Garraway, the company's chief medical officer.
[to top of second column] |
 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 authorized 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 antiviral drug remdesivir for treating
patients hospitalized with COVID-19, but a trial
mixing Actemra with remdesivir failed to cut
hospital stays.
($1 = 0.9170 Swiss francs)
(Reporting by Aishwarya Nair in Bengaluru and
John Miller in Zurich; Editing by Sherry
Jacob-Phillips and Mark Potter)
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