(RxWiki News) The US Food and Drug Administration (FDA) approved the first-ever treatment for COVID-19.
This new approval is for Veklury (remdesivir). The FDA approved it to treat both children and adults who have COVID-19 and require hospitalization.
“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," said FDA Commissioner Dr. Stephen M. Hahn in a press release.
For children, this medication was approved for those 12 years of age and older who weigh at least 40 kilograms (about 88 pounds).
Currently, it is not known whether this medication is safe and effective in children younger than 12 or those who weigh less than 40 kg.
This medication is available as an injection to be administered into the vein. It is given one time each day for up to 10 days. Your health care provider will determine the number of doses.
Remdesivir is only to be given in a hospital or health care setting.
Before its FDA approval, remdesivir was granted Emergency Use Authorization (EUA) for the treatment of hospitalized COVID-19 patients with severe illness.
This recent approval is supported by data from three randomized, controlled clinical trials that included patients who were hospitalized with mild to severe COVID-19.
A common side effect of Veklury was nausea. Other possible side effects included the following:
- Increased levels of liver enzymes
- Allergic reactions during or after infusion with remdesivir, potentially causing the following:
- Blood pressure and heart rate changes
- Low blood oxygen level
- Shortness of breath or wheezing
- Swelling of the lips, face or throat
- Sweating or shivering
Remdesivir's approval was granted to Gilead Sciences Inc.