FDA Authorizes Roche's Arthritis Drug Actemra for Emergency Use To Treat Severe COVID-19

Reuters  |

Video source: YouTube, CNBC Television

June 24 (Reuters) - U.S. health regulators have approved Roche's arthritis drug Actemra (tocilizumab) for emergency use to treat hospitalized COVID-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.

The U.S. Food and Drug Administration (FDA) said on Thursday it had issued an emergency use authorization (EUA) for Actemra to treat adults and pediatric patients hospitalized with COVID-19.

For months already, the medicine has been given to severely ill COVID-19 patients on a compassionate-use basis, generating hundreds of millions in sales for Roche. read more

The drug can be used to treat patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation, the FDA said, adding studies showed Actemra helped reduce risk of death and speed recovery.

The EUA is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients, Roche said.

In the first quarter, Actemra sales rose 22% to 779 million Swiss francs ($850 million), after surging nearly a third to 2.9 billion francs in 2020, mostly due to treatment of patients with severe COVID-19-associated pneumonia.

Though rising vaccinations in places such as Europe and the United States are reducing hospitalizations for COVID-19, Actemra is still being deployed for certain patients who land in the hospital.

Subscribe to get our Daily Fix delivered to your inbox 5 days a week

"Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalizations from severe forms of the disease,” said Levi Garraway, the company's chief medical officer.

Testing Actemra for COVID-19 patients involved trial and error, as successes in studies underpinning the FDA's EUA were accompanied by several failures in different patient groups as the Swiss company gathered knowledge about just who would benefit. read more

Actemra is not authorized for use in outpatients with COVID-19 or as a treatment for COVID-19, the health agency said.

Last year, the FDA approved Gilead Sciences Inc's antiviral drug remdesivir for treating patients hospitalized with COVID-19, but a trial mixing Actemra with remdesivir failed to cut hospital stays. read more

($1 = 0.9170 Swiss francs)

Reporting by Aishwarya Nair in Bengaluru; Editing by Arun Koyyur.

_____

Source: Reuters, CNBC Television

Stock price data is provided by IEX Cloud on a 15-minute delayed basis. Chart price data is provided by TradingView on a 15-minute delayed basis.

Trending Articles

Cisco Down 12% in Premarket Trading Thursday After Top Line Miss and Lower Forecast
Under Armour CEO Patrik Frisk To Step Down in Surprise Announcement
Target Hits 52-Week Low After Missing Badly on First Quarter Earnings
DLocal Posts Record Q1, Fifth Consecutive 100%+ Revenue Growth Quarter
Another Crypto Winter Wipes Out Billions in Market Value
Inflation + Recession = Recipe for Volatility
Twitter Down 13% in Premarket Trading Friday as Musk Puts Deal on Hold
The Best Laid Plans of Mice and Men — Part I

Market Movers

Sponsored Financial Content