The European Medicines Agency (EMA) has recommended granting a licence for baricitinib (Olumiant) to treat moderate to severe atopic dermatitis in adults who are candidates for systemic therapy.
It is estimated that up to 7 per cent of adults in Europe have atopic dermatitis. The proportion with the moderate to severe form of the disease is approximately 30 per cent. One in four adults with the disease report its onset in adulthood.
Baricitinib works by blocking the action of Janus kinases (JAKs) that mediate the pathways involved in the inflammatory process in atopic dermatitis. It is the first JAK inhibitor to treat moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy in the EU.
The EMA opinion is based mainly on data from three 16-week phase 3 randomised double blind, placebo-controlled studies. In all three studies baricitinib was shown to be more effective than placebo in reaching Investigator Global Assessment 0 or 1 at week 16.
The most common side effects included increased LDL cholesterol, upper respiratory tract infections and headache.
The EMA opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.