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FDA Issues Emergency Approval To Lilly's Arthritis Drug With Remdesivir For COVID-19 Treatment

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The U.S. Food and Drug Administration issued an emergency use authorization for Eli Lilly and Co.'s (LLY) rheumatoid arthritis drug baricitinib, in combination with Gilead Sciences' (GILD) remdesivir, to treat COVID-19 patients.

The FDA has authorized the drug combination 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 or ECMO.

The drug combination was given emergency approval based on a clinical trial that found it reduced time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir.

The FDA said that the safety and effectiveness of the 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 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.

Baricitinib is an oral JAK inhibitor discovered by Incyte (INCY) and licensed to Lilly. It is commercially available as Olumiant in the U.S. and more than 70 countries and was recently approved in the European Union for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.

Earlier this month, the FDA granted emergency use authorization for Eli Lilly's investigational monoclonal antibody therapy bamlanivimab or LY-CoV555 for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients 12 years and older.

Gilead Sciences' Remdesivir is an FDA-approved intravenous antiviral drug, sold under the brand name Veklury.

Remdesivir also remains authorized for emergency use for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients.

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