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Eli Lilly's Olumiant Becomes First FDA Approved Immunomodulatory Treatment For COVID-19

  • The FDA approved Eli Lilly And Co’s LLY Olumiant (baricitinib) for COVID-19 in hospitalized adults requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 
  • Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval. 
  • The FDA first issued an emergency use authorization (EUA) for Olumiant combined with remdesivir to treat COVID-19 in hospitalized adults and pediatric patients in November 2020.
  • Related: Eli Lilly Achieves 80% Jump In COVID-19 Therapy Sales, Revises FY22 Guidance.
  • In July 2021, the FDA revised the EUA to authorize Olumiant as a standalone treatment. 
  • Olumiant remains under EUA status for hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, mechanical ventilation, or ECMO. 
  • The FDA has revised the Letter of Authorization and associated fact sheets to remove the population covered under the approved indication. 
  • Price Action: LLY shares closed 0.08% higher at $285.70 during after-hours trading on Tuesday.

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