Healthcare company Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ: INCY) on Thursday jointly announced the US Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) for the distribution and emergency use of baricitinib in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19.

The partnership added the use of baricitinib is authorized only for the duration of patient's requirement of supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

However, the FDA's EUA authorization is temporary. This is the first combination regimen authorized by US FDA. The evaluation of baricitinib's efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials.

This EUA is based on data from the Adaptive COVID-19 Treatment Trial (ACTT-2), a randomized double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib in combination with remdesivir versus placebo with remdesivir in hospitalized patients with or without oxygen requirements conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The recommended dose for this EUA is baricitinib 4-mg once daily for 14 days or until hospital discharge.

Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly, which is working with hospitals, healthcare professionals and governments to facilitate patient access to baricitinib and continues to explore the medicine's potential use in COVID-19.