New FDA Leader Accelerates Solutions

The U.S. Food and Drug Administration (FDA) new leader said in a statement ‘it wants to assure the American public that the agency continues to expedite the development and availability of critical products to prevent the SARS-CoV-2 coronavirus.’

‘Including repurposing existing therapies that may help treat patients suffering from COVID-19 disease.’

The FDA’s 24th Commissioner, Stephen M. Hahn, M.D., said on March 19, 2020, “We understand and recognize the urgency with which we are all seeking prevention and treatment options for COVID-19.”

“We also must ensure these products are effective; otherwise we risk treating patients with a product that might not work when they could have pursued other, more appropriate, treatments.” 

“If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it.” 

“We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus,” concluded Dr. Hahn, the previous chief medical executive at The University of Texas MD Anderson Cancer Center, located in Houston.

While the FDA says there are ‘no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19’, there are several FDA-approved treatments that may help ease the symptoms from a supportive care perspective, such as the following:

• 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.
• 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 study the drug under the FDA’s investigational new drug requirements. To date, the agency has already granted about 250 patients access to this product.
• 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 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 says ’it is taking the lead on an urgent cross-government approach to facilitate the development of all of these products.’

And, ‘is closely monitoring the market to combat these products with fraudulent claims. It is unacceptable that anyone would take advantage of Americans during this public health crisis.’

The FDA is 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.

Coronavirus treatment news published by Precision Vaccinations.