President Trump announced that the Food and Drug Administration (FDA) has granted emergency use authorization for Gilead Sciences’ remdesivir drug to treat hospitalized patients with COVID-19.
The company began developing the drug in 2009 as a potential treatment for Ebola, but new data from two global clinical trials suggest that the intravenous drug has helped shorten the recovery time of some hospitalized COVID-19 patients.
Although remdesivir has not been formally approved to treat the virus and the new data has yet to be peer-reviewed, the emergency use authorization grants permission to medical professionals to use the drug on patients hospitalized with COVID-19.
According to an FDA fact sheet on remdesivir, “there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19.”
However, director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci said earlier this week on Wednesday that data from a drug trial testing remdesivir suggested that the drug could become the standard of care for patients with COVID-19.
The National Institute of Allergy and Infectious Diseases released preliminary results from its Adaptive COVID-19 Treatment Trial which indicate that patients who received remdesivir had a 31 percent faster recovery time than those who received placebo. Patients who took remdesivir usually recovered after 11 days, four days faster than those who did not take the drug. 1,063 patients were enrolled in the drug trial.
Gilead Sciences also released preliminary results from its own study with 397 patients who had severe cases of COVID-19. The first trial evaluated the safety and efficacy of 5-day and 10-day dosing regimens of remdesivir in the hospitalized patients. At least 50 percent of the patients treated with a 5-day dosage of remdesivir improved. However, the trial did not use a control group of patients to evaluate the data.
On Thursday, the company said it expects to produce more than 140,000 rounds of its 10-day treatment regimen by the end of May and will hopefully make 1 million rounds by the end of this year. Gilead Sciences is also in the middle of its second trial in which results from the first 600 patients are expected to be released by the end of May. Furthermore, an expansion phase of the first trial was recently added and will enroll an additional 5,600 patients from around the world.
Under the emergency use authorization, the FDA will allow the drug to be administered for either a 5-day or a 10-day dose. A 10-day treatment regimen is preferred for intubated patients.
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