Xaluprine is granted a Europe-wide licence
Nova Laboratories, a specialist in aseptic processing of complex pharmaceuticals, has been granted a Europe-wide licence for a liquid formulation of mercaptopurine, for the treatment of acute lymphoblastic leukaemia.
The European Commission has granted orphan status to Xaluprine (mercaptopurine 20mg/ml oral suspension) and distribution to pharmacies and hospital pharmacies throughout Europe has begun.
The European Medicines Agency’s Paediatric Committee identified the development of an age-appropriate formulation to treat this disease as a priority research area, and Nova, which is based in Leicester, UK, has spent more than three years on the project.
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 difficult for parents or carers to administer an accurate dose to young children.
Xaluprine 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.
Dr Peter White, Nova’s managing and technical director, said Xaluprine is a significant development in the treatment of childhood leukaemia.
‘Xaluprine will bring great benefits to young children and their carers, in terms of improved accuracy of dosage and consistency of formulation, and we will therefore ensure that supplies are available in every European country over the next few months,’ he said.
‘This is our first own-brand product, and will help secure Nova’s long-term future.’
Trimedica Limited will be the exclusive distributor in Europe for Xaluprine.
Nova is now conducting further clinical work to provide additional data for a licence submission in the autumn to market the product in the US.