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Article Source: Immediate Medicine News
Today, the US FDA revised the emergency use authorization (EUA) of baricitinib (brand name Olumiant), and now authorizes baritinib to be used alone for the treatment of assisted oxygen supply, non-invasive or invasive mechanical ventilation or extracorporeal membrane lung Oxygenation (ECMO) hospitalized adults and pediatric COVID-19 patients 2 years of age or older
.
According to the revised EUA, baritinib no longer needs to be administered with remdesivir (Veklury)
This revision of the EUA of baritinib is supported by data from a clinical trial for COVID-19 hospitalized patients.
The trial showed that compared with patients who received only standard treatment for COVID-19, baritinib was 28% The proportion of patients who died during the follow-up period decreased
.
This clinical study does not require the combination of baritinib and remdesivir, and most patients in the study did not receive remdesivir treatment
The COV-BARRIER study in a randomized, double-blind, placebo-controlled clinical trial (NCT04421027) in hospitalized adult patients diagnosed with COVID-19 infection compared baritinib 4 mg once daily (n=764) with placebo (N=761) Treatment
.
Patients can continue to receive standard treatment as defined by local guidelines, including antimalarials, antivirals, corticosteroids, and/or azithromycin
Although the revised EUA no longer requires baritinib and remdesivir to be used together, the FDA’s authorization indicates that the COV-BARRIER trial that supports this revision did not trigger any concerns about baritinib and remdesivir.
The combined use of Wei to treat the safety or efficacy of COVID-19 patients who need auxiliary oxygen, non-invasive or invasive mechanical ventilation or ECMO to be hospitalized
.
Remdesivir was previously approved by the FDA in October 2020 for the treatment of adults and children (12 years and older, weighing at least 40 kg) COVID-19 patients who need to be hospitalized
.
In November 2020, the FDA granted an EUA for the combination therapy of baritinib and remdesivir for adults and children with suspected or confirmed COVID-19 who require assisted oxygen supply, invasive mechanical ventilation, or extracorporeal membrane oxygenation ( 2 years old or older) emergency use for hospitalized patients
Reference materials:
[1] FDA authorizes baricitinib alone as treatment for COVID-19.
