EMA has started evaluating an application to extend the use of Olumiant (baricitinib) to include treatment of COVID-19 in hospitalised patients from 10 years of age who require supplemental oxygen.
Olumiant is an immunosuppressant (a medicine that reduces the activity of the immune system). It is currently authorised for use in adults with moderate to severe rheumatoid arthritis or atopic dermatitis (eczema). Its active substance, baricitinib, blocks the action of enzymes called Janus kinases that play an important role in immune processes that lead to inflammation. It is thought that this could also help reduce the inflammation and tissue damage associated with severe COVID-19 infection.
The active substance in Olumiant, baricitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system). It works by blocking the action of enzymes known as Janus kinases. These enzymes play an important role in the processes of inflammation and damage that occur in rheumatoid arthritis and atopic dermatitis. By blocking the enzymes, baricitinib reduces joint and skin inflammation and other symptoms of these diseases.
EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Olumiant, including results from 2 large randomised studies in patients hospitalised with COVID-19, in order to recommend as soon as possible whether or not the extension of indication should be authorised. The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
The company that markets Olumiant will ensure that doctors who are expected to prescribe the medicine receive an information pack on the risks with Olumiant, particularly the risk of infection and blood clots, and the monitoring that should be carried out in patients. Patients will be given a special alert card that summarises the safety information about the medicine.
EMA will communicate on the outcome of its evaluation, which is expected to reach an opinion by July unless supplementary information is needed.
Source: European Medicines Agency