medwireNews: Sarilumab has been approved by the European Commission for the treatment of adult patients with moderate-to-severe rheumatoid arthritis (RA).
The European announcement follows approval of the interleukin (IL)-6 receptor antagonist by the US FDA in May 2017.
In Europe, sarilumab is indicated for patients with an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). The European Medicines Agency (EMA) specifies that sarilumab should be used in combination with methotrexate, but it can be given as a monotherapy if patients are unable to take methotrexate.
The recommended dose is 200 mg given as a subcutaneous injection once every 2 weeks, but the dose can be lowered for patients with abnormal blood tests. As sarilumab is associated with infection risk, the EMA recommends that patients should be monitored closely for signs of infection during treatment.
The European product information for sarilumab carries a black triangle label for additional monitoring, meaning that its long-term effects will be examined more closely than those of other medicines.
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