Drug used for autoimmune diseases also approved as treatment for COVID-19 without combination

The United States Drug Regulatory Authority, known by its acronym FDA, has cleared the emergency use of the drug baricitinib as a non-combination treatment for COVID-19. The drug has already been indicated since 2017 in patients with rheumatoid arthritis, an autoimmune disease. With the development of the pandemic since the end of 2019, Research has been initiated into the possibility of its use to treat coronavirus infection. Now, the regulatory authority has deemed that there is no longer any evidence to give the green light to the administration of baricitinib only in certain groups of patients with COVID-19.

According to the regulatory agency, baricitinib may be indicated for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age and older who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). “Under the revised emergency authorization, it is no longer necessary to administer baricitinib with remdesivir”, reported in a press release. He clarified that the authorization does not yet imply “approval” as a treatment for COVID-19.

The emergency clearance mechanism has also already been used by the FDA with COVID-19 vaccines. The federal agency is applying it to speed up use because “it recognizes the seriousness of the current public health emergency and the importance of facilitating the availability” of vaccines and treatments.

Authorization of the drug baricitinib has been supported by data from a clinical trial in hospitalized patients with COVID-19. As rated the drug demonstrated a reduction in the proportion of patients who died during 28 days of follow-up compared to patients treated only with standard treatment for COVID-19.

“This study did not require that baricitinib be used in combination with remdesivir, and most patients did not receive remdesivir. This study provided information that was previously not available to the agency at the time of the initial authorization, ”said the regulator.

Although he allowed it, the FDA has also reported that the drug can cause side effects. “The possible side effects of baricitinib include serious infections, blood clots, changes in the results of some lab tests, and allergic reactions,” he said.

In Argentina, the regulatory authority, ANMAT, approved baricitinib in 2018 for patients with rheumatoid arthritis. In June 2020, it authorized a controlled clinical trial for patients who had contracted COVID-19 infection in the country.

Before the pandemic, Baricitinib has been used alone or with other medicines to treat rheumatoid arthritis, a disease in which the body attacks its own joints, causing pain, swelling and loss of function. It has been given to adults who have not responded well to one or more tumor necrosis factor inhibitors. It belongs to a class of drugs that inhibit a type of enzyme and work by reducing the activity of the immune system.

The COV-BARRIER trial supporting this review, reported by the FDA on Wednesday, July 28, “raised no concerns regarding the safety or efficacy of baricitinib when used in combination with remdesivir” for the treatment of patients hospitalized for COVID-19 requiring supplemental oxygen, invasive or invasive mechanical non-ventilation, or ECMO. As well it was clarified that the use of baricitinib in combination with remdesivir is not contraindicated in the terms and conditions of the new authorization.

The other medicine, Remdesivir is licensed in the United States for the treatment of COVID-19 in hospitalized adults and pediatric patients (over the age of 12 and weighing 40 pounds or more) requiring hospitalization. Remdesivir also remains approved for emergency use for the treatment of COVID-19 in pediatric patients.

In Argentina, ANMAT approved remdesivir in COVID-19 cases at the end of April. It is only administered intravenously in a hospital setting. A few days ago, the laboratory that markets remdesivir announced the positive results of three retrospective studies of the treatment of hospital patients with COVID-19 in the real world.

These results were presented at the World Microbe Forum (WMF). It was observed that in the general patient population, those who received treatment with remdesivir had a significantly lower risk of mortality compared to matched controls. A reduction in mortality was envisioned over a spectrum of baseline oxygen requirements.

The three data analyzes included 98,654 hospitalized COVID-19 patients and the results were seen consistently at different times during the pandemic and in all geographies.. Two retrospective studies analyzed treatment trends and effects in the United States from the HealthVerity and Premier Healthcare databases. It was found that patients who received remdesivir were significantly more likely to be discharged from the hospital on day 28.

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