The Food and Drug Administration (FDA) in the United States has approved Gilead Science Inc’s (GILD.O) drug remdesivir for emergency use against COVID-19.
On Friday, 1 May, President Donald Trump announced the news at the white house. Stephen Hahn, the Food and Drug Administration (FDA) commissioner too was present and said, remdesivir would be available for hospitalized COVID-19 patients, The Guardian reported.
Trump said the new development is a “very promising situation.”
Since there is no cure for coronavirus so far, the interest in remdesivir has been high, as reported by FIT earlier.
Stephen Hahn added, “It’s the first authorized therapy for COVID-19, so we’re really proud to be part of it.”
Earlier, a government-sponsored study, including 1,063 patients had shown that Gilead Sciences’ remdesivir reduced the time to recovery for hospitalized COVID-19 patients by 31%.
Dr Anthony Fauci, a top US health advisor and director at the US National Institute of Allergy and Infectious Diseases (NIAID), had claimed earlier this week that the drug could have ‘clear-cut’ power to fight the novel coronavirus. There has been a lot of conflicting studies and reports on the efficacy of this drug which had failed as a treatment against Ebola previously.
It should be noted that the emergency use authorization also gave information about potential side effects that include “increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating and shivering”.
Remdesivir was previously available only for patients enrolled in clinical trials or for patients cleared to get the drug under expanded use and compassionate use programs, reported Reuters.