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FDA is working closely with partners across the U.S. government & regulated industry to expedite the development & availability of medical products to prevent & treat #COVID19, including repurposing existing therapies that may help treat #COVID19 patients. fda.gov/news-events/pr…
While there are no FDA-approved therapeutics or drugs to treat, cure, or prevent #COVID19, there are several FDA-approved treatments that may help ease symptoms from a supportive care perspective.
FDA continues to work with interested sponsors to help expedite any additional clinical trials for #COVID19 medical countermeasures that may be appropriate. We are able to, and have been, turning around requests very quickly to assist in initiating clinical trials.
For example, last month, @NIH began a randomized controlled trial with the investigational antiviral drug remdesivir. Through its expanded access program, FDA has also granted emergency use of this product to about 250 patients. niaid.nih.gov/news-events/ni…
Additionally, a randomized controlled trial of the antiviral drug sarilumab, an antibody to the IL-6 receptor is underway. IL-6 receptor inhibitors are thought to be potentially helpful in reducing lung information & improving lung function in #COVID19 patients.
There’s also interest in evaluating whether therapies, such as convalescent plasma & hyperimmune globulin—antibody-rich blood products that are taken from blood donated by people who have recovered from the virus—could shorten the length, or lessen the severity, of the illness.
Facilitating the ultimate widespread use & availability of safe & effective #COVID19 medical countermeasures is critical for many reasons, including that reducing the severity & duration of symptoms could help lessen the burden on medical personnel, equipment & facilities.
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