With this emergency use authorization (EUA) the US Food and Drug Administration is allowing caregivers to dose adults (and pediatric patients above the age of two) with a combination of baricitinib (a janus kinase inhibitor) and the antiviral remdesivir. The EUA covers dosing of patients who are on supplemental oxygen, o or receiving invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The data supporting the issued EUA reportedly are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2) conducted by the National Institute of Allergy and Infectious Diseases (NIAID). The trial evaluated whether baricitinib impacted how long it took for subjects who were also taking remdesivir to recover from COVID-19.
According to researchers, the combination of baricitinib and remdesivir reportedly was shown to reduce time to recovery within 29 days after initiating treatment, in comparison to patients receiving remdesivir and a placebo. To date, baricitinib has not received approval to be used as a stand-alone treatment for COVID-19.
FDA commissioner Stephen Hahn said this EUA is the latest in the FDA’s series of actions designed to bring effective COVID-19 treatments to healthcare providers and patients.
“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” he said. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
Baricitinib is a janus kinase inhibitor, a therapy that blocks the activity of one or more enzymes in order to interfere with the pathway that leads to inflammation. Sold by Eli Lilly under the brand name Olumiant, baricitinib is a prescription oral tablet medication previously FDA-approved for the treatment of moderately to severely active rheumatoid arthritis.
Remdesivir, sold by Gilead under the brand name Veklury, is an intravenous antiviral treatment indicated for hospitalized adult and pediatric COVID-19 patients 12 years or older of age and older and weighing at least 40 kilograms (about 88 pounds). Remdesivir remains under EUA for the treatment of 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.
Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said, “Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients.”
In October, the FDA issued its first approval for remdesivir/Veklury in treating COVID-19 patients.