The approval does not cover use with the entire population covered under the prior emergency use authorization.
The U.S. Food and Drug Administration (FDA) has approved Verklury (remdesivir) as the first treatment of COVID-19.
According to a news release, the drug should be used with adult and pediatric patients aged 12 and older who weigh at least 88 pounds requiring hospitalization due to their COVID-19. It should only be used in a hospital or healthcare setting capable of providing care comparable to an inpatient hospital.
It notes that the approval does not cover the whole population that was covered by remdesivir’s emergency use authorization (EUA) which was issued in May. The FDA revised the EUA so that pediatric patients undergoing the therapy who do not meet the above age and size requirements can continue to receive the treatment while clinical trials on the efficacy and safety in this group are ongoing.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Stephen M. Hahn, MD, says in the release. “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.”
According to the release, the possible side effects include: increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (lips, around eyes, under the skin), rash, nausea, sweating or shivering.
In June, remdesivir manufacturer Gilead announced that the drug will cost $390 a vial in developed countries. As patients are expected to receive a five-day treatment course using six vials of remdesivir, the total cost for the treatment will be about $2,340 per patient. Even at that price, the drug is expected to produce hospital savings of about $12,000 per patient, due to earlier discharge.