Roche is looking to get the label expanded on RoActemra on both sides of the Atlantic to cover treatment of a particular form of arthritis that affects children.
The Swiss major has submitted a supplemental Biologics License Application to the US Food and Drug Administration and an accelerated assessment application to the European Medicines Agency to extend the license on RoActemra (tocilizumab), known as Actemtra in the USA, for the treatment of systemic juvenile idiopathic arthritis (sJIA). There are currently no approved therapies for sJIA, which is characterised by inflammatory arthritis accompanied by intermittent fever, skin rash, anaemia, enlargement of the liver and/or spleen and inflammation of the lining of the heart and/or lungs.
The peak age of onset of sJIA is between 18 months and two years, Roche noted, although persistence of the disease into adulthood occurs. It has "the worst long-term prognosis of all childhood arthritis subtypes", accounting for almost two-thirds of all deaths among children with arthritis, with an overall mortality rate estimated to be between 2%-4%. Current treatment consists of high-dose corticosteroids "which do not improve the long-term prognosis and are often accompanied by severe side effects," the company added.
The applications are based on data from the Phase III study which demonstrated that 85% of patients on RoActemra for three months had a 30% improvement in the signs and symptoms of sJIA and absence of fever, a primary characteristic of sthe disease, compared to 24% of patients who received placebo. Roche chief medical officer Hal Barron said that "with these striking data we hope RoActemra may become a treatment option that benefits children and their families living with this condition every day".
The drug is currently licenced in Europe for use in combination with methotrexate to treat adults with moderate to severe rheumatoid arthritis who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs or tumour necrosis factor antagonists. It was approved by the FDA in January for moderately to severely active RA in adults who have not responsed to one or more TNF inhibitors.