Eli Lilly and Incyte have secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for baricitinib plus remdesivir to treat hospitalised patients with Covid-19.
The EUA status facilitates distribution and emergency use of baricitinib in combination with remdesivir in hospitalised adult and paediatric patients two years of age or older with suspected or laboratory confirmed Covid-19 who need supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Baricitinib is an oral JAK inhibitor discovered by Incyte and licenced to Lilly. It is approved and commercially available as Olumiant in the US and over 70 countries to treat adults with moderate to severe rheumatoid arthritis (RA).
Recently, baricitinib was approved in the European Union (EU) to treat adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Incyte CEO Hervé Hoppeno said: “We are pleased that the FDA has authorized the use of baricitinib in combination with remdesivir for COVID-19, and look forward to the opportunity to make more therapies available to patients around the world affected by the global pandemic.”
The regulator has provided EUA status for baricitinib plus remdesivir based on data from the Adaptive Covid-19 Treatment Trial (ACTT-2).
The randomised double-blind and placebo-controlled study was designed to assess the efficacy and safety of baricitinib plus remdesivir versus placebo with remdesivir in hospitalised 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).
All patients secured standard supportive care by the trial site hospital, and the recommended dose for this EUA is baricitinib 4mg once daily for 14 days or until hospital discharge.
Lilly chairman and CEO David Ricks said: “Today’s FDA action for baricitinib marks the second Lilly therapy to be granted an EUA, in addition to the recent neutralising antibody EUA for high-risk non-hospitalized patients, increasing the number of treatment options for Covid-19 patients at different stages of the disease.
“This is an important milestone for hospitalised patients on oxygen, as baricitinib may help speed their recovery.”