Baricitinib tablets for COVID-19: All about Remdesivir, Baricitinib's effectiveness

Indian drugmaker Cipla Ltd on May 10 announced that it entered into a licensing agreement with the American company Eli Lilly and Co to make and sell Lilly's arthritis drug Baricitinib for the treatment of COVID-19 patients. The agreement came as India is battling with the crippling second wave of the coronavirus outbreak with a drastic surge of COVID-19 patients leaving hospitals across the nation overwhelmed. Further, the country is also tackling the shortage of drugs such as Remdesivir and tocilizumab used globally to treat patients with highly infectious disease. 

Baricitinib has also received the restricted emergency use approval by India’s drug regulator for use in combination with Remdesivir for the treatment of the hospitalised COVID-19 adult patients that require supplemental oxygen. Meanwhile, in November 2020, the United States Food and Drug Administration (FDA) gave Eli Lilly an emergency use approval for Baricitinib in combination with Remdesivir for the COVID-19 patients.

When is Baricitinib given to COVID-19 patients?

Central Drugs Standard Control Organisation (CDSCO) in India on Monday gave drugmaker Natco Pharma the emergency use approval for Baricitinib tablets - 1 mg, 2 mg and 4 mg strengths. The company said in its regulatory filing, “Natco Pharma Ltd has received emergency use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India.” Natco also said that it will request a compulsory license based on emergency use and in the wake of the COVID-19 situation in the country. 

In October 2020, US-based Elli Lilly had cited additional data to state that “Baricitinib in combination with Remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with Remdesivir.” The American drugmaker also revealed after a study that the “largest benefits” of Baricitinib “were observed in patients requiring supplemental oxygen (grade 5 on the eight-point ordinal scale) and those who required high-flow oxygen/non-invasive ventilation (grade 6) at baseline.”

The new data from the study, which was sponsored by the National Insitute of Allergy and Infectious Diseases (NIAID) that is a part of the National Institutes of Health (NIH), also showed that the clinical outcomes were also improved among the hospitalised adult COVID-19 patients after Baricitinib was administered.

Efficacy of Baricitinib plus Remdesivir treatment

In a study by NIH, the researchers concluded that the combination of an anti-inflammatory drug, Baricitinib plus an antiviral, Remdesivir “reduced time to recovery for people hospitalised with COVID-19. The results of the study were published in the New England Journal of Medicine in December 2020 as part of the second iteration of the NIH Adaptive COVID-19 Treatment Trial (ACTT-2). ACTT-2 is a study protocol to evaluate the treatments for hospitalised patients of COVID-19. 

The researchers wrote, “the combination of Baricitinib and Remdesivir reduced median time to recovery in hospitalized COVID-19 patients from eight days to seven days. Patients who required high-flow oxygen or non-invasive ventilation during their hospitalization appeared to have had the largest benefit: their median time to recovery was shortened from 18 days to ten days.”

“In addition, participants’ conditions at day 15 of the study (as measured by an eight-category ordinal scale which ranked the severity of their condition) was significantly improved when they received the two therapeutics combined. Recipients of the two treatments also had slightly fewer serious adverse effects,” they added.

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