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"The filing for ACTEMRA represents a significant milestone for Roche, andbrings us another step closer to making this important therapy available tothe millions of patients in the United States who suffer from the agonizingpain and debilitating effects associated with rheumatoid arthritis," saidGeorge Abercrombie, President and CEO, Hoffmann-La Roche Inc.
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ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibitingmonoclonal antibody and represents a novel mechanism of action to treat RA.Research suggests that reducing the activity of IL-6, one of several keycytokines involved in the inflammatory process, may reduce inflammation of thejoints and relieve certain systemic effects of RA.
The BLA submission to the FDA is based on results from five internationalPhase III studies which demonstrated ACTEMRA as monotherapy or in combinationwith disease modifying anti-rheumatic drugs (DMARDs) such as methotrexatesignificantly reduced the signs and symptoms of rheumatoid arthritis asmeasured by ACR -- as well as achieving disease activity score (DAS) remission-- compared to DMARD therapies alone. Furthermore, patients who had previouslyfailed anti-tumor necrosis factor (anti-TNF) treatments also showedsignificant improvement in signs and symptoms of RA after treatment withACTEMRA.
Roche will file a Marketing Authorization Application (MAA) for ACTEMRAwith the European Medicines Agency (EMEA) in early December.
About ACTEMRA
The clinical development program conducted by Roche includes five clinicalstudies and has enrolled more than 4,000 patients in 40 countries, includingthe U.S. One of these Phase III trials evaluating ACTEMRA in RA is an ongoingtwo-year study and is expected to report one-year data evaluating the effectof ACTEMRA on the inhibition of structural damage in 2008.
ACTEMRA is part of a co-development agreement with Chugai, a Japanesecompany. ACTEMRA was launched in Japan by Chugai in June 2005 as a therapy forCastleman's disease. Additional indications for RA and systemic-onset juvenileidiopathic arthritis were also filed in Japan in April 2006 and are currentlyunder review.
The serious adverse events reported in ACTEMRA clinical trials wereserious infections and hypersensitivity reactions including anaphylaxis. Themost common adverse events reported in clinical studies were upper respiratorytract infection, nasopharyngitis, headache and hypertension. Increases inliver function tests (ALT and AST) were seen in some patients; these increaseswere generally mild and reversible, with no hepatic injuries or any observedimpact on liver function.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune diseasecharacterized by inflammation of the membrane lining in the joints. Thisinflammation causes a loss of joint shape and function, resulting in pain,stiffness and swelling, ultimately leading to irreversible joint destructionand disability. Characteristics of RA include redness, swelling, pain andmovement limitation around joints of the hands, feet, elbows, knees and neckthat leads to loss of function. In addition, the systemic symptoms of RAinclude fatigue, decreased hemoglobin and osteoporosis and may contribute toshortening life expectancy by affecting major organ systems. After 10 years,less than 50% of patients can continue to work or function normally on a dailybasis. RA affects more than 21 million people worldwide with approximately 2.1million people affected in the U.S.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.
