The US FDA will fast-track potential antiviral medications to treat coronavirus, President Donald Trump announced at a White House briefing Thursday. However, FDA commissioner Dr Steven Hahn said the drugs will require clinical testing first.
The generic drug hydroxychloroquine, which is already approved to treat malaria, was one of the therapeutics the President directed the FDA to look at as a potential COVID-19 therapy. The other, Gilead Sciences Ebola antiviral Remdesivir, has been successful at treating two other coronaviruses: Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), USA Today reported. The National Institutes of Health (NIH) began a randomized controlled trial for Remdesivir last month.
“We have to remove every barrier or a lot of barriers that were unnecessary and they’ve done that to get the rapid deployment of safe, effective treatments and we think we have some good answers,” The President said at the briefing.
The FDA continues to work to expedite the development and availability of critical medical products to prevent and treat this novel virus, including repurposing existing therapies that may help treat patients with COVID-19.
“We are looking at everything that’s coming across our desks as possible treatments for coronavirus,” FDA commissioner Hahn said at the same White House briefing.
“We understand and recognize the urgency with which we are all seeking prevention and treatment options for COVID-19. FDA staff are working expeditiously on that front,” he added in a statement. “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.”
The FDA also noted that some antiviral drugs that might treat the specific virus, as well as host targets, such as interleukin-6 (IL-6) receptor inhibitors, are being looked at. These “may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients, thereby potentially slowing the progression of severe respiratory symptoms,” the FDA said. 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.”