Roche announced today that its partner Chugai has received notification from the Japanese Ministry of Health, Labour and Welfare (MHLW) that the ACTEMRA conditions for approval have been lifted for the rheumatoid arthritis (RA) and polyarticular-course juvenile idiopathic arthritis (pJIA) indications.
As part of the conditions for Japanese approval for ACTEMRA in RA and pJIA, and similar to all other biologics, the Japanese Health Authorities require a Post Marketing Surveillance (PMS) programme to occur in approximately the first 3,000 patients treated. Patients receive the treatment in pre-registered hospitals and are followed up for six months of therapy in the programme.
Data on 3,987 patients with RA and pJIA were submitted to the Japanese MHLW as the interim analysis results of the PMS programme.(1) Based on the results, it has been determined that the safety and efficacy profiles of ACTEMRA are consistent with those identified in the Phase III clinical trials. Therefore, the condition that all RA and pJIA patients receiving ACTEMRA should be included in a post marketing surveillance study has been lifted.
Until now the usage for ACTEMRA has been restricted to those doctors who have previous experience with biologics, in registered hospitals. The lifting of the restrictions now means ACTEMRA can be used more widely, outside the pre-registered hospitals.
“The PMS data in Japan adds to the robust body of evidence supporting ACTEMRA as an effective treatment for RA patients”, commented Hal Barron, M.D, Head of Global Development and Chief Medical Officer for Roche. “The lifting of this condition for approval of ACTEMRA by the Japanese health authorities is great news for patients as it means they will have improved access to this important medicine”.
ACTEMRA is currently licensed in Japan for the treatment of RA, pJIA, sJIA and Castleman’s disease. The PMS programme for ACTEMRA’s use in systemic juvenile idiopathic arthritis (sJIA) and Castleman’s Disease is still ongoing and new patients continue to be enrolled because of the rarity of the diseases.