Roche announced today that the European Commission (EC) has extended RoACTEMRA’s indication to reduce the rate of progression of joint damage and improve physical function in patients with rheumatoid arthritis (RA), when given in combination with methotrexate (MTX). The licence extension comes just over a year after initial approval and further reinforces RoACTEMRA as an effective treatment for RA.
Joint damage in RA often begins early in the disease and can lead to permanent disability. Therefore, inhibiting this structural damage to patients’ joints is a critical measure of the effectiveness of an RA treatment. For patients this means that they may be able to continue to enjoy their lives without the worsening disability usually associated with the disease.
The approval from the EC was based on positive two-year data from the phase III LITHE trial. This trial demonstrated that patients receiving RoACTEMRA in combination with MTX had significantly less damage to their joints at two years, compared to patients in the control group. The outcome was determined by x-rays which measured over time the progression of bone erosions and narrowing of joint spaces. The data showed that with long-term use, patients with RA treated with RoACTEMRA 8mg/kg plus MTX suffered 81% less damage to their joints compared to those treated in the control group at week 104.
“The extended licence approval granted by the EC today is great news for patients,” said Hal Barron, M.D, executive vice president, Global Development and chief medical officer. “This licence extension is based on robust Phase III data which not only demonstrates joint damage inhibition but consistently demonstrates high signs and symptoms remission rates across a range of RA patient types.”
RoACTEMRA is currently licenced in Europe for use in combination with MTX, to treat adult patients with moderate to severe RA who responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor antagonists (anti-TNFs). In these patients, RoACTEMRA can be given as monotherapy in cases of intolerance to MTX, or where continued treatment with MTX is inappropriate.
RoACTEMRA (ACTEMRA as it is known in the US) was filed in the US in March 2010 for the prevention of structural joint damage and to improve physical function in adults with moderately to severely active RA. This filing followed ACTEMRA’s approval by the FDA in January 2010 as the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody to treat adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.