Basel, 04 August 2010
ACTEMRA approval conditions lifted by Japanese Health Authorities
Roche (SIX: RO, ROG; OTCQX: RHHBY) 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. 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.
About the Japanese Post Marketing Surveillance Programme
Over 10,000 patients have been enrolled in the Japanese Post Marketing Surveillance Programme to date and the results of the final analysis of safety data will be reported as soon as the data become available.
For the interim analysis, data on 3,987 patients with RA (3,881 patients) and pJIA (106 patients) who were enrolled between April 16, 2008 and July 15, 2009 were evaluated, in order to obtain additional information on the safety and efficacy of the drug at an early stage to ensure safe use of the drug in Japan. The results were as follows:
The incidence of adverse drug reactions was 37.9%, in which the incidence of serious adverse drug reactions accounted for 8.0%. The most frequent adverse drug reactions were "abnormal laboratory test values" and "infections and infestations". The most frequent serious adverse drug reactions were "infections and infestations". The Japanese Post Marketing safety profile was consistent with the clinical trial data. The efficacy was evaluated using DAS28(*). 2,072 patients’ DAS28 values were collected before the administration of ACTEMRA and at the 28th week. The high disease activity score of DAS28 (mean±SD) 5.53±1.30 before administration markedly improved to 3.00±1.49 at the 28th week. The DAS28 remission rate at the 28th week was 45.0%.
(*) The Disease Activity Score (DAS) 28 is a combined index that measures disease activity in patients with RA. It combines information from 28 tender and swollen joints (range 0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. The level of disease activity is interpreted as low (DAS28 < 3.2), moderate (3.2 < DAS28 < 5.1) or high (DAS28 > 5.1). DAS28 < 2.6 corresponds to being in remission according to the criteria of the American Rheumatism Association (ARA).
RoACTEMRA/ACTEMRA is the result of research collaboration by Chugai and is also being co-developed globally with Chugai. RoACTEMRA/ACTEMRA is the first humanised interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development programme of five Phase III trials was designed to evaluate clinical findings of RoACTEMRA/ACTEMRA, all of which met their primary endpoints. RoACTEMRA/ACTEMRA was first approved in Japan, and launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. RoACTEMRA/ACTEMRA was approved in the European Union in January 2009 for the treatment of RA in patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) inhibitors. It is also approved for use in several other countries, including India, Brazil, Switzerland, and Australia. RoACTEMRA/ACTEMRA was most recently (January 2010) approved in the United States for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more TNF inhibitors.
The overall safety profile of RoACTEMRA/ACTEMRA is consistent across all global clinical studies. The serious adverse events reported in RoACTEMRA/ACTEMRA clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse events reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver enzymes (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no evidence of hepatic injuries or any observed impact on liver function. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in some patients without association with clinical outcomes. Treatments that suppress the immune system, such as ACTEMRA, may cause an increase in the risk of malignancies.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
All trademarks used or mentioned in this release are protected by law.