The U.S. Food and Drug Administration has announced it is continuing to work with the public and private sectors to ensure the availability of life-saving drugs. Innovators are looking at various products, including the assessment of antiviral drugs that might treat the coronavirus, as well as host inhibitors that may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients.
“As is true for most medical situations, the great American innovators in academia and industry have engaged with us about treatment options,” said FDA Commissioner Stephen Hahn, M.D.
The FDA is working with partners across the U.S. government and industry to expedite the development of critical medical products, including repurposing existing therapies that may help treat patients with COVID-19.
The FDA also said the agency is leveraging scientific information about the virus and trials currently being conducted in countries such as China, Japan, South Korea, and Italy as well as in the U.S.
Last month, the National Institutes of Health (NIH) began a randomized controlled trial for the treatment of COVID-19 patients with an investigational antiviral drug. Earlier last week, NIH announced the start of the Phase 1 clinical trial in Seattle in 45 healthy adult volunteers to test the safety of an investigational vaccine designed to protect against COVID-19 infection.
The FDA has also been working with the drug sponsor, Gilead Sciences Inc. to find multiple pathways to both study the drug under the FDA’s investigational new drug requirements, and collect helpful data about the efficacy of the drug, as well as provide the drug to patients under emergency use.
Regeneron Pharmaceuticals Inc. has announced a clinical trial of sarilumab, an antibody to the IL-6 receptor, to assess whether the modification of the inflammatory response by this treatment provides benefit to COVID-19 patients.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.