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Celgene’s Vidaza wins wider approval for acute myeloid leukaemia

Elderly patients to gain access to cancer drug

The European Commission has expanded the use of Celgene's Vidaza to treat elderly patients with acute myeloid leukaemia.

The new indication for Vidaza (azacitidine) is for patients aged over 65 with acute myeloid leukaemia (AML) who are not eligible for haematopoietic stem cell transplant.

The EC's approval comes on the back of data showing that median overall survival rate was 10.4 months versus 6.5 months for those taking conventional treatment.

Tuomo Patsi, president of Celgene in Europe, Middle East and Africa, said: “Celgene is committed to bringing innovative medicines with haematological diseases including AML.

“The approval of Vidaza in this segment of AML patients now gives us a new opportunity to help these patients and underscores our commitment to delivering medicines that can have a significant impact on patients with severe and debilitating diseases.

Our next step will be to work with each of the member countries to provide access to Vidaza in this indication, ensuring that patients who can benefit from its use have the opportunity to do so.”

Vidaza was granted a positive opinion by the EMA's Committee for Medicinal Products for Human Use earlier this year in September.

Individuals with AML have white blood cells, called myeloblasts that are disrupted. The resulting effect is numerous non-functioning white cells, which can potentially interfere with the body's ability to control infections and can lead to anaemia and haemorrhages.

More than 14,000 people suffer from AML in Europe and most die within a year after being diagnosed.

Vidaza was first approved in Europe in 2008. Last year it brought in $612m in global sales. 

Article by
Nikhil Patel

2nd November 2015

From: Regulatory



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