EMA has recommended granting an extension of indication to Olumiant (baricitinib) to include the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. Olumiant is already approved in the European Union to treat moderate to severe active rheumatoid arthritis, a disease causing inflammation of the joints.
Atopic dermatitis (also known as eczema, an itchy red rash of the skin) is a chronic inflammatory skin disease that occurs most frequently in children but also in adults. While in children most cases clear up spontaneously, the disease can persist or start in adulthood. In Europe, it is estimated that up to 7% of adults have atopic dermatitis and the proportion of adults with the moderate to severe form of the disease is approximately 30%. One in four adults with the disease report its onset in adulthood.
Atopic dermatitis causes skin lesions, itchy skin, skin pain, sleep disturbance and is commonly associated with the occurrence of other atopic conditions such as asthma and allergic rhinitis (hay fever). It may lead to difficult-to-control scratching, skin inflammation and infections, functional impairment and mental distress, and feelings of anxiety and depression.
Patients with mild forms of the disease are generally treated with emollients (moisturisers) and topical corticosteroids (creams used to reduce swelling and redness during flare-ups), and/or topical calcineurin inhibitors. However, patients with moderate to severe atopic dermatitis require additional therapies to control their skin inflammation and alleviate the most bothersome symptoms. Systemic treatment options are limited and there is still a need for new treatment options.
Olumiant works by blocking the action of enzymes known as 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 and offers a different mode of action to the currently available treatment options. It is the first medicine for moderate as well as severe atopic dermatitis that patients can take orally.
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