FDA Grants Priority Review To Roche's Actemra For Hospitalized COVID-19 Adults

The FDA has granted priority review to Roche Holdings AG's RHHBY Actemra/RoActemra (tocilizumab) for COVID-19 in hospitalized adults.
"If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for treating COVID-19 in hospitalized patients," Roche said.
The Compay also added that more than 1 million people hospitalized with COVID-19 had been treated with Actemra/RoActemra worldwide since the beginning of the pandemic.
The supplemental application submission is based on results from four studies of Actemra/RoActemra for COVID-19 in more than 5,500 hospitalized patients.
Altogether, these four studies suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
In June 2021, Actemra/RoActemra received FDA Emergency Use Authorization for use in patients hospitalized with severe or critical COVID-19.
Following the emergence of the omicron variant, in December 2021, WHO reported that interleukin-6 receptor blockers, such as Actemra/RoActemra, are expected to be still effective for managing patients with severe COVID-19.
Price Action: RHHBY shares are trading higher by 1.64% at $51.32 on the last check Monday.