Japanese company Eisai has announced that its US subsidiary Eisai Medical Research will begin trials of Dacogen for injection in paediatric patients with acute myelogenous leukaemia (AML) in the US.
The clinical trial will be conducted in accordance with a Written Request issued by the US Food and Drug Administration (FDA).
If the FDA determines that the data from the clinical trial appropriately meet requirements set out in the Written Request, six-month paediatric exclusivity will be granted for Dacogen, extending its patent to November 2013.
Dacogen has already been approved by the FDA and is indicated in the US for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS.
AML is a life-threatening disease and the most common form of acute leukaemia. It is estimated that the US incidence of AML in children age 0–14 is 6.9 per one million people.