Get all your news in one place.
100’s of premium titles.
One app.
Start reading
Benzinga
Benzinga
Technology
Vandana Singh

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

FDA Roche RHHBY Roche Holdings AG WHO United States
  • The FDA has granted priority review to Roche Holdings AG's (OTC: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.
Sign up to read this article
Read news from 100’s of titles, curated specifically for you.
Already a member? Sign in here
Related Stories
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member? Sign in here
Our Picks
Ninja Slushi review: Should you buy or skip it?
The Ninja Slushi is a fun appliance for turning liquids into slush quickly, quietly, and with minimal clean-up. But knowing the caveats, is it worth buying for $299, or should you skip it?
Tom’s Guide
Tom’s Guide
“My eyebrows are singed, my mouth is blistered, my arms are pretty bad”: Slipknot’s Sid Wilson is hospitalised with “serious burns” following farming accident
Slipknot DJ Sid Wilson reveals he has suffered burns to his face and arms after an explosion, assures fans that he’ll still play upcoming shows
Metal Hammer
Metal Hammer
Phil Donahue obituary
Unpretentious US talkshow host whose popularity was built on addressing women’s issues and involving the audience
The Guardian - UK
The Guardian - UK
Does eating ham, bacon and beef really increase your risk of developing type 2 diabetes?
That lunchtime staple, the humble ham sandwich, has come in for a bashing in the press recently. According to many reports, eating two slices of ham a day can increase your risk of developing type 2 diabetes.
The Conversation
The Conversation
Why Rotten Tomatoes’ ratings overhaul does no one any favours
The review aggregator website is giving increased prominence to ‘audience scores’, with critically panned dreck scooping up top grades. It’s the sign of something bigger and more troubling in our culture, writes Louis Chilton
The Independent UK
The Independent UK
Supermassive black holes have masses of more than a million suns – but their growth has slowed as the universe aged
Supermassive black holes have masses of more than a million suns – but their growth has slowed as the universe aged
Space
Space
Fourteen days free
Download the app
One app. One membership.
100+ trusted global sources.
Download on the AppStore Get it on Google Play