The FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug CHLOROQUINE, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy of using chloroquine to treat COVID-19.
Last month, the National Institutes of Health (NIH) began a randomized controlled trial for the treatment of COVID-19 patients with the investigational antiviral drug REMDESIVIR. The FDA has 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 thus collect helpful data about the efficacy of the drug, as well as provide the drug to patients under emergency use.
Innovators are looking at products in a variety of areas, including the assessment of antiviral drugs that might treat the specific virus, as well as host targets, such as interleukin-6 (IL-6) receptor inhibitors that may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients, thereby potentially slowing the progression of severe respiratory symptoms. Regeneron Pharmaceuticals Inc has announced the initiation of a randomized controlled 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.
There’s also interest in evaluating whether therapies, such as convalescent plasma and 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. The FDA is taking the lead on an urgent cross-government approach to facilitate the development of all of these products.
At the same time, the FDA will continue work to facilitate the development of treatment options in the near-term, the agency is also working with interagency partners, product developers, and international public health organizations to expedite the development of vaccines to the greatest extent possible. In fact, earlier this week, NIH announced the start of a 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 intends to use all of the regulatory flexibility granted to it by Congress to ensure the most efficient and timely development of vaccines to fight COVID-19.