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)

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