Roche gains RoActemra European Approval for children with RA
The European Commission has approved the use of RoActemra (tocilizumab) for the treatment of active sJIA in patients two years of age and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs and systemic corticosteroids (used to treat inflammation). RoActemta (known as Actemra outside Europe) can be given alone or in combination with methotrexate, and was recently approved in the USA for children.
sJIA is the rarest form of juvenile rheumatoid arthritis. The disease affects about 10 to 20 percent of children with JIA, with the peak age of onset between 18 months and two years, although the disease can persist into adulthood. sJIA has a two to four percent overall estimated mortality rate, and accounts for almost two-thirds of all deaths among children with arthritis. The severity varies from person to person and it can include symptoms ranging from joint inflammation accompanied by intermittent fever, skin rash, anaemia, enlargement of the liver or spleen and inflammation of the lining of the heart and/or lungs.
Roche’s chief medical officer Hal Barron said the approval is an important advance in the treatment of sJIA, noting that RoActemra “is the first and only biological treatment to demonstrate significant efficacy in this patient population”. The drug, which targets the interleukin-6 pathway, is currently used for the treatment of adult RA.