The Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for a promising new drug cocktail for hospitalized CCP virus patients.
The treatment involves combining remdesivir with the anti-inflammatory oral drug baricitinib for patients 2 years of age or older who need supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), according to the FDA.
Remdesivir is an anti-viral, administered intravenously, previously approved by the FDA for use in CCP (Chinese Communist Party) virus patients 12 years of age or older. It is sold under the brand name Veklury.
Baricitinib blocks the activity of certain enzymes, interfering with pathways that lead to inflammation. Sold under the brand name Olumiant, the drug was earlier approved by the FDA for the treatment of rheumatoid arthritis.
“Under today’s EUA, the FDA is authorizing the emergency use of baricitinib, in combination with remdesivir, for the treatment of certain hospitalized patients with suspected or laboratory-confirmed COVID-19,” health officials said.
The FDA said it took the decision to give the drug combination an emergency use nod after weighing the potential risks with the benefits of their use in a public health emergency.
“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn in a statement.
The FDA’s decision came after it conducted a randomized, double-blind, placebo-controlled clinical trial, which compared the use of remdesivir plus baricitinib, versus remdesivir and a placebo. The results, which the FDA says are statistically significant, showed faster recovery for CCP virus patients who used the drug combination and reduced the likelihood of patients dying or having to be ventilated.
The FDA’s emergency use decision is part of the agency’s Coronavirus Treatment Acceleration Program, “which uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”
Treatments being studied fall into several categories: antiviral drugs, immunomodulators—which aim to tamp down the body’s sometimes dangerously severe reaction to CCP virus infection, antibody therapies—including blood-derived products like convalescent plasma, as well as cell and gene therapies.
As of Oct. 31, there were 30-plus drug combinations, like the remdesivir and baricitinib pair, being studied under the Coronavirus Treatment Acceleration Program.