The FDA has officially approved remdesivir for the treatment of adults and children (over the age of 12 and weighing at least 40 kg) who have been hospitalized for COVID-19. This decision comes after the FDA allowed remdesivir to be used as a treatment in severe cases, which was announced back in May. As more information is discovered, and the pandemic continues to have severe impacts on the US, the FDA feels that it is both safe and necessary for this treatment to be more widely available to COVID-19 patients.
Remdesivir and the Pandemic
Back in March, the FDA announced that the emergency use of drugs and biological products was allowed due to the severe nature of the pandemic. Soon after, they released that remdesivir could be used to treat severe cases of COVID-19. As the drug had not yet been approved, this decision was a big one.
After a few months the FDA had more data on remdesivir and the pandemic was still raging. Because of this, on August 28, the FDA reissued their letter from March and stated that this drug could be used for all hospitalized cases of COVID-19.
That brings us to October. On the first day of the month they announced that Gilead Sciences Inc. was to be responsible for the distribution of remdesivir. 16 days later they released a revised letter, which defined alternate care sites as a hospital setting, therefore allowing remdesivir to be administered at these sites.
The Latest Update
The FDA released their latest update on the drug on October 22. This letter stated that remdesivir was approved for the treatment of adults and children who have been hospitalized for COVID-19.
Data from three trials has driven the FDA to make this decision. They believe that these studies prove that the benefits, both potential and known, outweigh the current standard of care. Because of this, they have approved remdesivir.
You can read the full letter from the FDA here.