Child leukaemia drug approved for Australia market

UK-based Nova Laboratories is to start supplying Xaluprine to Australian child leukaemia patients just weeks after opening up the US marketplace.

Through a partnership with specialist pharmaceutical and medical technologies business LINK Healthcare, it has won approval for its acute lymphoblastic leukaemia (ALL) product from the Therapeutics Goods Association in Australia.

The drug will be known as Allmercap in Australia and distributed by LINK Healthcare. It is a 20 mg/mL oral suspension of the existing ALL treatment, mercaptopurine, which until now has only been available in as a tablet in Australia.

It was developed by Nova to meet a need for greater dosing accuracy and improved palatability for children. Mercaptopurine has been available as a 50-mg 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.  

Nova says that the oral suspension offers more consistent absorption than the tablet, allows doses to be individualised to an accuracy of 2 mg, is easier for young patients to swallow and with a natural raspberry flavour, more palatable.

Mr John Bacon, chairman of LINK Healthcare, said: “While ALL is rare, it is the most common childhood cancer especially in the 2–5 age group and this formulation should help ensure parents ensure their children get the treatment they need”.

Nova won the FDA licence to market the drug in the US in April 2014, where it is distributed as Purixan by Rare Disease Therapeutics Inc.

Dr Hussain Mulla, head of clinical development for Nova said:  “We are proud that by securing Australian approval, right after the FDA approval for our first licensed product, we are helping fight this disease on three continents. But we still intend to develop further worldwide markets to help children living with ALL.

Nova first launched Xaluprine in Europe in 2012 following marketing authorisation from the European Commission.