US FDA expands Emergency Use Authorization (EUA) for baricitinib for treatment of hospitalised patients with Covid-19 to include treatment with or without remdesivir
The previous EUA required use in combination with remdesivir. Under the expanded EUA, based on data from the COV-BARRIER study, baricitinib can be used to treat adults and paediatrics aged ≥2 who need supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
Source:
Biospace Inc.
SPS commentary:
The European Medicines Agency is currently reviewing an application seeking to extend the use of the Janus kinase (JAK)1 and JAK2 inhibitor to include treatment of hospitalised patients with Covid-19 requiring supplemental oxygen in patients aged ≥10 years. Baricitinib is currently licensed in the UK for the treatment of rheumatoid arthritis and atopic dermatitis.