Jyseleca is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease in which the immune system (the body’s natural defences) attacks healthy tissue to cause inflammation and pain in joints. Jyseleca is used alone or with another medicine, methotrexate, after treatment with one or more disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or causes unacceptable side effects. DMARDs are medicines, such as methotrexate, that slow down worsening of the disease. Jyseleca contains the active substance filgotinib.

Filgotinib, the active substance in Jyseleca reduces the activity of the immune system. It does this by blocking the action of enzymes known as Janus kinases (JAKs). These enzymes play an important role in the inflammatory process that occurs in rheumatoid arthritis. By blocking the enzymes’ action, filgotinib can help to reduce symptoms of rheumatoid arthritis

Studies have shown that Jyseleca alone or in combination with methotrexate is effective for treating moderate to severe rheumatoid arthritis when previous treatment with DMARDs had not worked well enough. In general, the side effects of Jyseleca were similar to those of other medicines of its class and the most important side effect is infection. There is also concern that it might reduce fertility in men. Specific warnings and information material are available to help manage these risks. The European Medicines Agency decided that Jyseleca’s benefits are greater than its risks and it can be authorised for use in the EU.