Janssen-Cilag International NV announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of DACOGEN® (decitabine) for Injection. The CHMP is recommending that DACOGEN be indicated for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
The CHMP is the committee responsible for the scientific assessment of products seeking centralised marketing authorisation throughout the European Union. The CHMP´s positive opinion is now referred for approval to the European Commission. Janssen anticipates receiving the regulatory decision from the Commission towards the end of the third quarter of 2012.
The CHMP positive opinion is based on data from the DACO-016 trial, the largest AML trial to date in this population of older patients. This randomized, open-label, multi-centre phase 3 clinical trial compared DACOGEN versus patient´s choice with physician´s advice of either supportive care or low-dose cytarabine in patients 65 years and older with newly diagnosed de novo or secondary acute myeloid leukemia (AML) and poor- or intermediate-risk cytogenetics. DACOGEN was administered at 20 mg/m2 as a 1-hour intravenous infusion once daily for five consecutive days, repeated every four weeks, continued as long as the patient derived benefit. Key results from this study were published in the Journal of Clinical Oncology in June 20121.
"Older AML sufferers face very limited options for treatment," commented Jane Griffiths, Company Group Chairman, Janssen Europe, Middle-East, Africa. "We are thrilled with today´s CHMP announcement and will continue to work closely with health authorities to make DACOGEN available to fight this life-threatening illness."
About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is an aggressive, fast-growing cancer that starts inside the bone marrow with production of abnormal blood cells. It is generally a disease of older adults, with an average patient age of 64 at diagnosis, and is slightly more common among men than women. The most common symptoms of AML include tiredness, shortness of breath, bruising or bleeding easily, fever and infections. AML can sometimes spread to other parts of the body including the lymph nodes, liver and spleen. When diagnosed, treatment is to be started with minimal delay as AML usually results in death within just a few months if left untreated. In older adults, induction chemotherapy leads to a high 30-day mortality, and most patients are not candidates for or are unwilling to undergo this intensive therapy. Therefore, treatment options are limited and overall, irrespective of therapy, median survival is merely 2.4 months.
About DACOGEN (decitabine)
DACOGEN is a DNA hypomethylating agent currently approved for the treatment of myelodysplastic syndromes (MDS) in more than 30 countries worldwide including key markets such as the United States, Brazil, China, India, Korea, Russia and Turkey.
Janssen-Cilag International NV and its affiliates hold marketing and development rights for DACOGEN in all markets except the United States, Canada and Mexico, where rights are maintained by our partner, Eisai Inc. and its affiliates.
About Janssen
Janssen-Cilag International NV is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, which are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).
Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at www.janssen-emea.com
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International N.V. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson´s Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen-Cilag International N.V. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
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Reference :
1 Kantarjian M., Thomas XG, Dmoszynska A, et al. Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia. J Clin Oncol. 10.1200/JCO.2011.38.9429
