Janssen-Cilag receives positive opinion from EMA CHMP for DACOGEN

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 2012.

"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."


Janssen-Cilag International NV



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