EMA approves extended Xaluprine shelf life

The European Medicines Agency (EMA) has approved an extension of the in-use shelf life for Xaluprine – a liquid formulation of acute lymphoblastic leukaemia (ALL) treatment mercaptopurine.

The in-use shelf life of the product is now 56 days – double the previous amount.

Its manufacturer, UK-based Nova Laboratories, said the extension would reduce wastage, particularly for young children who require smaller doses.

Nova is set to issue updated packaging to its European customers by the end of June through distributor Trimedica.

Hussain Mulla, head of clinical development at Nova, said the news was a positive step in the treatment of ALL across Europe:

“Many pharmacists acknowledge the superior benefits of prescribing mercaptopurine in liquid form, as opposed to tablets, in terms of palatability, dosing accuracy and safety, but face downward pressure on costs.

“The EMA ruling means that for younger patients the product is now effectively half its original cost, which we hope will encourage pharmacists to consider it as a more viable option.”

Xaluprine is now widely available throughout Europe including the UK and Ireland, the Netherlands, Germany and Scandinavia, with discussions underway with most other EU countries.

The product is exclusively distributed in Europe by Trimedica Limited. For all enquiries please contact: [email protected] or call Matt Jelley, Commercial Director, on 0044(0)755 752 7112