Link Healthcare secures marketing approval for ALLMERCAP™ for the treatment of acute lymphoblastic leukaemia (ALL)

Specialist pharmaceutical and medical technologies business, LINK Healthcare (‘LINK’) has secured marketing approval for its acute lymphoblastic leukaemia (ALL) product ALLMERCAP™ through a partnership with the UK Company, Nova Laboratories.

The product is a 20mg/ml oral suspension of the existing ALL treatment mercaptopurine, which, prior to ALLMERCAP’s approval has only been available in Australia as a tablet.

The oral suspension was developed by Nova to meet a need for greater dosing accuracy and improved palatability for children. Mercaptopurine has been available as a 50mg tablet for many years, but because the dose has to be adjusted according to body surface area, it has always been extremely difficult for parents or carers to administer an accurate dose to young children.

The oral suspension offers more consistent absorption than the tablet and allows doses to be individualised to an accuracy of 2mg. It is also easier for young patients to swallow as the natural raspberry flavour ensures good palatability.

On April 28, 2014, in a written announcement to Clinical Oncologists, the US Food and Drug administration (FDA) said: “Compared to tablets, a suspension offers the advantage of more accurately delivering the desired doses to children with a wide range of weights using a consistent administration schedule. A suspension will allow more flexibility in adjusting the dose” and that “a commercially produced suspension is more likely to provide a more consistent dose of 6-mercaptopurine than ad hoc compounded formulations.”

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