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news.UK-based Nova Laboratories has received approval from the US Food and Drug Administration (FDA) for its acute lymphoblastic leukemia (ALL) drug Xaluprine, which will be marketed as Purixan in the US.
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Purixan is a 20mg/ml oral suspension of existing ALL treatment mercaptopurine. Prior to Xaluprine and Purixan, mercaptopurine has only been available as a 50mg tablet for many years. Nova Laboratories filed a New Drug Application with the FDA for Purixan in July 2013.
The company has developed the drug in order to meet a need for greater dosing accuracy and improved palatability for children. The FDA granted orphan drug status for the product.
According to Nova Laboratories, 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.
Nova Laboratories said that compared to tablet form, the oral suspension offers more consistent absorption and allows doses to be individualized to an accuracy of 2mg.
Additionally, the oral suspension is also easier for young patients to swallow and the natural raspberry flavor ensures good palatability.
The FDA has approved Purixan based on clinical pharmacology research to assess the bioequivalence of mercaptopurine tablets with that of the oral suspension version.
Rare Disease Therapeutics will now distribute the ALL drug in the US.
Nova Laboratories first launched Xaluprine – its maiden licensed product – in Europe in 2012.
Nova Laboratories clinical development head Dr Hussain Mulla noted that following success in Europe, the company is now looking to develop further worldwide markets to help children living with this disease.