Ash Stevens manufactures leukaemia API
children in more than a decade was approved as Ash Stevens are to
manufacture Clofarabine, the active ingredient in Clolar, used to
treat acute lymphoblastic leukaemia (ALL).
The news comes after the US Food and Drug Administration (FDA) granted approval for clofarabine (CLOLAR), a purine nucleoside antimetabolite, for treatment of paediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukaemia after at least two prior regimens.
"Clofarabine is a new drug for those suffering from certain forms of leukaemia and requiring salvage therapy," said Dr. Stephen Munk, President of Ash Stevens.
"This is Ash Stevens' third approval to manufacture a novel, New Chemical Entity from the FDA in under two years," he added.
In 2005, an estimated 3,400 new cases of paediatric acute leukaemia will be diagnosed in the United States, according to Cancer Metric. ALL is the most common form of paediatric leukaemia and children who do not respond to initial therapy, or who relapse, have a very poor survival prognosis.
Clolar has already received Orphan Drug designation for adult and paediatric acute lymphoblastic leukaemia. Clolar will now have seven years of market exclusivity in paediatric ALL patients. The FDA also recently granted six months of extended market exclusivity to Clolar under the Best Pharmaceuticals for Children Act.
