Washington, DC – The US Food and Drug Administration (FDA) on Thursday issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected COVID-19 or laboratory confirmed in hospitalized adults and pediatric patients 2 years of age and older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
In a clinical trial of hospitalized COVID-19 patients, baricitinib, in combination with remdesivir, was shown to reduce recovery time within 29 days of starting treatment compared to patients who received a placebo with remdesivir.
The safety and efficacy of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated. Baricitinib is not licensed or approved as a standalone treatment for COVID-19.
“Today’s action demonstrates the FDA’s unwavering efforts to make potential COVID-19 treatments available in a timely manner, when appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said the Commissioner of the FDA, Stephen Hahn, MD in written communication.
“As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use all possible avenues to provide new treatments to patients as quickly as possible to combat COVID-19,” he added.
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 that is FDA approved (and sold under the brand name Olumiant) for the treatment of moderate to severe active rheumatoid arthritis.
According to today’s USA, the FDA authorizes the emergency use of baricitinib, in combination with remdesivir, for the treatment of certain hospitalized patients with suspected or laboratory confirmed COVID-19.
Remdesivir is an intravenous antiviral drug approved by the FDA (and sold under the brand name Veklury) for use in adult and pediatric patients 12 years of age or older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID -19 requiring hospitalization. Remdesivir also remains licensed for emergency use for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg (approximately 7.7 pounds) to less than 40 kg or inpatient pediatric patients under the age of 12 years old weighing at least 3.5 kg. kg.
“The FDA emergency authorization of this combination therapy represents a step forward in the treatment of COVID-19 in hospitalized patients and the first FDA authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.
“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 identify therapies that delay disease progression and reduce disease. mortality in the sickest patients ”, he added.
Issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of the available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the totality of available scientific evidence, the agency has determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the licensed population. And, when used under the conditions outlined in the US to treat COVID-19, the known and potential benefits of baricitinib outweigh the known and potential risks of the drug. There are no suitable, approved, and available alternative treatments to baricitinib, when used 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 ECMO.
The data supporting this AU 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 affected the time it took for subjects 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; 515 patients received baricitinib plus remdesivir and 518 patients received placebo plus remdesivir. Recovery was defined as hospital discharge or hospitalization, but did not require supplemental oxygen and no longer required ongoing medical care. The median recovery time from COVID-19 was seven days for baricitinib plus remdesivir and eight days for placebo plus remdesivir. The odds that a patient’s disease would progress to death or be ventilated on day 29 was lower in the baricitinib plus remdesivir group than in the placebo plus remdesivir group. The odds of clinical improvement at day 15 were higher in the baricitinib plus remdesivir group than in the placebo plus remdesivir group. For all of these endpoints, the effects were statistically significant.
According to the EUA, fact sheets providing important information on the use of baricitinib in combination with remdesivir in the treatment of COVID-19 as authorized should be available to healthcare providers and to patients and caregivers. These fact sheets include dosing instructions, possible side effects, and drug interactions. Possible side effects of baricitinib in combination with remdesivir include serious infections, blood clots, changes in certain laboratory test results, and allergic reactions.
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use and medical devices for human use. and veterinarian. The agency is also responsible for the security of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating our nation’s tobacco products.