United States approves drug Roche for emergency use against severe COVID-19 – .

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Signage can be seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, USA on August 29, 2020. REUTERS / Andrew Kelly

  • Reused anti-inflammatory drug wins emergency green light from FDA
  • Revenue from Actemra’s use of COVID-19 has already increased
  • Actemra’s studies for COVID have had successes, failures

June 24 (Reuters) – U.S. health regulators have approved Roche’s arthritis drug (ROG.S) Actemra for emergency use to treat COVID-19 hospital patients, giving a boost additional to a drug that was already authorized for humanitarian reasons.

The United States Food and Drug Administration (FDA) announced Thursday that it has issued an Emergency Use Authorization (EUA) to Actemra to treat adults and pediatric patients hospitalized with COVID-19.

For months now, the drug has been administered to critically ill COVID-19 patients on a compassionate basis, generating hundreds of millions in sales for Roche. Read more

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

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

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

Although increased vaccinations in places like Europe and the United States are reducing hospitalizations for COVID-19, Actemra is still deployed for some patients who land in hospital.

“Even with the availability of vaccines and the decline in deaths from COVID-19 in various parts of the world, we continue to see new hospitalizations due to severe forms of the disease,” said Levi Garraway, medical director of the business.

Actemra’s testing for COVID-19 patients involved trial and error, as the successes of the studies supporting the FDA’s EUA were accompanied by several failures in different patient groups as the Swiss company gathered knowledge about who would benefit. Read more

Actemra is not licensed for outpatient use with COVID-19 or as a treatment for COVID-19, the health agency said.

Last year, the FDA approved remdesivir, an antiviral drug from Gilead Sciences Inc (GILD.O) for the treatment of hospital patients with COVID-19, but a trial mixing Actemra with remdesivir failed to reduce hospital stays. Read more

($ 1 = 0.9170 Swiss francs)

Reportage d’Aishwarya Nair à Bengaluru; Montage by Arun Koyyur

Our Standards: The Thomson Reuters Trust Principles.

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