FDA grants EUA for COVID-19 treatment for hospitalized patients

Nov. 20, 2020

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, 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 (ECMO).

The FDA said that in a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir. FDA said it is continuing to evaluate the safety and effectiveness of this investigational therapy for use in the treatment of COVID-19. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.

Separately, the World Health Organization (WHO) Guideline Development Group advised against the use of remdesivir for the treatment of patients hospitalized with COVID-19.

“The antiviral drug remdesivir is not suggested for patients admitted to hospital with covid-19, regardless of how severely ill they are, because there is currently no evidence that it improves survival or the need for ventilation,” the WHO Guideline Development Group (GDG) panel of international experts wrote in the journal BMJ.

Baricitinib is a janus kinase inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation. 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. Under the EUA, the FDA is authorizing the emergency use of baricitinib, in combination with remdesivir, for the treatment of certain hospitalized patients with suspected or laboratory-confirmed COVID-19.

The FDA EUA was issued to Eli Lilly and Company, the FDA said. The FDA also granted another EUA to Eli Lily this month for the company’s investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

Remdesivir is an FDA-approved (and sold under the brand name Veklury) intravenous antiviral drug for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Remdesivir also remains authorized for emergency use for the treatment of suspected or laboratory-confirmed 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.

The data supporting this EUA for baricitinib combined with remdesivir are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), which was conducted by the National Institute of Allergy and Infectious Diseases (NIAID). This clinical trial evaluated whether baricitinib impacted how long it took for subjects who were also taking remdesivir to recover from COVID-19.

The trial followed patients for 29 days and included 1,033 patients with moderate or severe COVID-19. A total of 515 patients received baricitinib plus remdesivir, and 518 patients received placebo plus remdesivir. Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was seven days for baricitinib plus remdesivir and eight days for placebo plus remdesivir. The odds of a patient’s condition progressing to death or being ventilated at day 29 was lower in the baricitinib plus remdesivir group versus the placebo plus remdesivir group. The odds of clinical improvement at day 15 was higher in the baricitinib plus remdesivir group versus the placebo plus remdesivir group. For all of these endpoints, the effects were statistically significant.

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