The FDA has approved the drug known as remdesivir for the treatment of COVID-19.
In a statement released earlier this evening, the Food and Drug Administration said that remdesivir is allowed for patients 12 and over who weigh about 88 pounds. Remdesivir is only permitted for use in hospitals or other medical care settings that provide inpatient care.
Since May hospitals have used remdesivir under an emergency use authorization, but only to treat those hospitalized with severe cases of COVID-19. It was later upgraded in August to include any child or adult admitted with COVID-19 symptoms.
With the new approval, the FDA expanded its use to include any patients, save for younger children, who are hospitalized with the virus. When President Trump was hospitalized with COVID-19 on Oct. 3, one of his treatments was remdesivir.
Mr. Trump has long been a supporter of remdesivir, made by the biotech firm Gilead Sciences. He said in late April that he wanted the FDA to move as quickly as it could to approve this anti-viral treatment. The drug works by stopping the coronavirus from reproducing itself.
The FDA based its approval decision on the results of three clinical trials. These trials tested remdesivir, which is given by infusion, on patients with different levels of severity and different recovery periods.
One trial tested the drug’s performance on 541 patients with mild, moderate and severe cases. A nearly equal of patients received a placebo. The remdesivir group, overall, took 10 days to either walk out of the hospital or remove their supplemental oxygen. Those who took the placebo took an average of 15 days were able to do the same.
A second trial looked at the drug’s performance in those with moderate diseases after 5 days, and also after 10 days, against standard of care. The drug worked best during the 5-day stretch. Those in the 10-day group fared better than those receiving standard of care, but statistically it wasn’t an important difference.
The third trial was devoted to those with severe disease. The nearly 400 patients were placed in either a 5-day evaluation period, or a 10-day. Again, those in the shorter period of time fared better than those in the longer period.
Not all remdesivir trials showed that this therapy produced good outcomes. A World Health Organization study, which looked at mortality rates among those with severe disease, found that those taking remdesivir fared no differently than those patients who had received other treatments or nothing.
Remdesivir is not a new drug. Gilead Sciences had developed remdesivir to treat viruses like hepatitis, SARS and Ebola. It did not receive approval for these diseases.
For patients with commercial insurance in the U.S., a course of remdesivir will cost $3,120, or $520 per vial. For those in government healthcare programs, the cost will be $2,340 per course of treatment.