FDA Provides Official Nod to Remdesivir
The FDA has approved the drug known as Remdesivir for the treatment of COVID-19.
In a statement released tonight, the Food and Drug Administration said remdesivir is allowed for patients 12 years and older who weigh around 88 pounds. Remdesivir is only approved for use in hospitals or other medical facilities that provide inpatient care.
Hospitals have been using Remdesivir as part of an emergency permit since May, but only to treat patients with severe COVID-19 cases. It was updated later in August to include any children or adults admitted with COVID-19 symptoms.
With the new approval, the FDA expanded its use to include all patients, except younger children, who are hospitalized with the virus. When President Trump was hospitalized with COVID-19 on October 3, one of his treatments was remdesivir.
Mr Trump has long been a supporter of remdesivir, which is made by biotech company Gilead Sciences. In late April, he said he wanted the FDA to move as quickly as possible to approve this antiviral treatment. The drug prevents the coronavirus from reproducing itself.
The FDA based its approval decision on the results of three clinical studies. In these studies, remdesivir, which is given by infusion, was tested in patients with varying degrees of severity and different recovery periods.
One study tested the drug’s performance in 541 patients with mild, moderate, and severe cases. Almost all patients received a placebo. It took the remdesivir group 10 days in total to either leave the hospital or remove their extra oxygen. Those who took the placebo took an average of 15 days to do the same.
A second study looked at the drug’s performance in patients with moderate disease after 5 days and also after 10 days against the standard of treatment. The drug worked best during the 5-day stretch. Those in the 10-day group did better than those who received a standard of care, but statistically this was not an important difference.
The third study was dedicated to people with serious illness. The nearly 400 patients were admitted to either a 5-day or a 10-day assessment period. Again, those in the shorter time did better than those in the longer time.
Not all remdesivir studies showed this therapy gave good results. A World Health Organization study that looked at the death rates of people with serious illness found that those who took remdesivir were no different from those who had received other treatments or nothing.
Remdesivir is not a new drug. Gilead Sciences developed Remdesivir to treat viruses such as hepatitis, SARS, and Ebola. It was not approved for these diseases.
For patients with commercial insurance in the US, a remdesivir course costs $ 3,120 or $ 520 per vial. For those participating in government health programs, the cost is $ 2,340 per course of treatment.