Roche: Actemra/RoActemra Gets FDA Emergency-Use Authorization for Covid-19 Treatment
June 25 2021 - 2:56AM
Dow Jones News
By Kim Richters
Roche Holding AG said Friday that it has received an
emergency-use authorization from the U.S. Food and Drug
Administration for its Actemra/RoActemra drug to treat certain
patients with Covid-19.
The Swiss pharmaceutical major said the authorization allows for
emergency use of Actemra/RoActemra for the treatment of Covid-19 in
hospitalized adults and children who are at least 2 years old.
The FDA's decision is based on the results of four randomized,
controlled studies with more than 5,500 hospitalized patients.
"The results of these studies suggest that Actemra/RoActemra may
improve outcomes in patients receiving corticosteroids and
requiring supplemental oxygen or breathing support," Roche
said.
Roche said this authorization is temporary and doesn't replace a
formal review and approval process.
Write to Kim Richters at kim.richters@wsj.com
(END) Dow Jones Newswires
June 25, 2021 02:42 ET (06:42 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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