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.
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Posted In: BiotechLarge CapNewsHealth CareFDAGeneralBriefsCOVID-19 Coronavirus
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