FDA approves Gilead's remdesivir as a coronavirus treatment
Why it matters: It's the first and only fully FDA-approved drug in the U.S. for treating the coronavirus.
The big picture: The FDA issued an emergency use authorization in May after treatment with the drug was found to shorten some hospitalized patients' recovery time. The full approval would likely expand its use.
Worth noting: President Trump was treated with remdesivir when he was hospitalized with COVID-19 earlier this month. He also received an experimental monoclonal antibody cocktail and the steroid dexamethasone.
What they're saying: “Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Gilead CEO Daniel O’Day said in a statement.
- “It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need.”
FDA Commissioner Stephen Hahn said in a statement: “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic."
- "As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”