FDA authorizes drug to treat certain hospitalized patients with COVID-19

Jun 25, 2021 - 03:10 PM
FDA product update

The Food and Drug Administration yesterday authorized for emergency use a new drug to treat hospitalized patients receiving systemic corticosteroids who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation. Actemra (tocilizumab) reduced the risk of death, ventilator use and time in the hospital for patients who received the drug in clinical trials. 

“Although vaccines have been successful in decreasing the number of patients with COVID-19 who require hospitalization, providing additional therapies for those who do become hospitalized is an important step in combating this pandemic,” said Patrizia Cavazzoni, M.D., director of FDA’s Center for Drug Evaluation and Research.

In other news, FDA is accepting comments through Aug. 24 on draft guidance encouraging clinical trials for cancer therapies to expand eligibility to patients with incurable cancers who have not previously received existing treatment options for their cancer. 
 

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