FDA Authorizes Drug Combination for Treatment of COVID-19

Washington, DC–the U.S. Food and Drug Administration issued an emergency use authorization (EUA) on November 19 for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.

Baricitinib is a janus kinase inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation. Baricitinib is a prescription oral tablet medication that is FDA-approved (and sold under the brand name Olumiant) for the treatment of moderately to severely active 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.

Remdesivir is an FDA-approved (and sold under the brand name Veklury) intravenous antiviral drug for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Remdesivir also remains authorized for emergency use for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg (about 7.7 pounds) to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.

The EUA was issued to Eli Lilly and Company.

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