Nova Laboratories secures FDA approval for Xaluprine

UK pharmaceutical firm Nova Laboratories has secured U.S Food and Drug Administration (FDA) approval for its acute lymphoblastic leukaemia (ALL) product Xaluprine, following a New Drug Application to the organisation in July 2013.

The drug, which will be marketed in the US as Purixan, is a 20mg/ml oral suspension of existing ALL treatment mercaptopurine, which, prior to Xaluprine and Purixan has only been available in tablet form.

It was developed by Nova to meet a need for greater dosing accuracy and improved palatability for children, and has been designated orphan drug status by the FDA – given to products intended for the treatment of rare diseases or conditions.

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 and the natural raspberry flavour ensures good palatability, its makers claim.

The approval was based on clinical pharmacology research¹ to assess the bioequivalence of mercaptopurine tablets with that of the oral suspension version.

The product will now be distributed throughout the US by Rare Disease Therapeutics Inc.

Dr Stephen Hunger, chairman of the Children’s Oncology Group ALL Disease Committee, Professor and Ergen Family Chair in Paediatric Cancer, and Director at the Center for Cancer and Blood Disorders at the University of Colorado School of Medicine, said:

“ALL therapy includes 6-mercaptopurine taken orally every day for 2-3 years.  Until now, the only FDA approved formulation of this drug available in the US has been pills, which can be very hard for young children to take.  This oral-suspension formulation should be much easier for young children to take and help parents to make sure that their children get the treatment that they need to cure ALL”.

On April 28, 2014, in a written announcement to Clinical Oncologists, the US Food and Drug administration said: “Compared to tablets, a suspension offers the advantage of more accurately delivering the desired dose 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.²”

Dr Hussain Mulla, head of clinical development for Nova said: “From our point of view we’re hugely proud that, thanks to this FDA approval, our product will contribute towards improved treatment of childhood cancer across the globe.

“We feel very privileged to be one of only a handful of UK-based companies to secure FDA approval of a new medicine, and for this to have been achieved with our first ever licensed product is especially pleasing.”

The FDA approved 95 New Drug Applications in 2013 – only nine of which were submitted by UK-based firms including four by GlaxoSmithKine.³

Traditionally a contract manufacturer on behalf of larger pharmaceutical firms, Nova first launched Xaluprine – its maiden licensed product – in Europe in 2012 following marketing authorisation from the European Commission.

Dr Mulla added: “Following success in Europe, we’re now looking to develop further worldwide markets to help children living with this disease.”

References

1. Mulla H, Leary A, White P and Pandya H, A Step Toward More Accurate Dosing for Mercaptopurine in Childhood Acute Lymphoblastic Leukemia, Journal of  Clinical Pharmacology (2012);52:1610-1613.
2. FDA release dated 29/04/2014
3. Source: Drugs@FDA (http://www.fda.gov/Drugs/InformationOnDrugs/default.htm)