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FDA approval for Nova’s leukaemia drug

Purixan expected to provide more accurate dosing for children
FDA headquarters White Oak

Nova Laboratories' drug Purixan has won approval in the US to treat a rare form of leukaemia.

The FDA gave the green light for the drug – an oral suspension formulation of mercaptopurine – to treat acute lymphoblastic leukaemia (ALL), paving the way for the drug to be distributed throughout the US by Nova's partner, specialist orphan drug company Rare Disease Therapeutics.

Mercaptopurine, which is marketed outside the US as Xaluprine, has been available for several years as a tablet. However, Nova said this has formula has led to problems in dosing due to the need to adjust according to the body surface area of a patient – many of whom are children.

“The oral suspension offers more consistent absorption than the tablet and allows doses to be individualised to an accuracy of 2mg,” said the company in a statement.

Clinical trials to support the approval demonstrated that Purixan/ Xaluprine is bioequivalent to mercaptopurine tablets.

The drug is the first licensed product from UK-based Nova, which was founded in 1994 by ex-NHS pharmacy staff and also has a manufacturing business.

The European Medicines Agency (EMA) recommended the drug back in March 2012 when, as per the FDA, it was assessed as an orphan drug due to the relative rarity of ALL.

According to the American Cancer Society, there were about 6,020 new cases of ALL in the US in 2014 and about 1,440 deaths attributable to the disease, which starts from white blood cells in the bone marrow and is most commonly found in children.

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.”

Article by
Thomas Meek

2nd May 2014

From: Sales



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