CHMP backs Nova Laboratories’ Mercaptopurine oral suspension
Nova receives a positive opinion from the CHMP for the leukaemia drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a marketing authorisation for Mercaptopurine Nova Laboratories (mercaptopurine monohydrate) for the treatment of acute lymphoblastic leukaemia in adults, adolescents and children.
Leicester-based Nova Laboratories has formulated the drug as a suspension, which it says provides improved accuracy and easier administration, as well as more flexible and consistent dosing.
Nova has spent more than two years on the project. Mercaptopurine Nova Laboratories was designated as an orphan drug in 2009.
The active substance of Mercaptopurine Nova Laboratories is mercaptopurine, a cytotoxic purine analogue (L01BB02) that interferes with nucleic acid metabolism and inhibits growth of malignant cells.
John Seaton, financial and commercial director for Nova Laboratories, said: ‘This is a very important development in the treatment of leukaemia, especially for the benefits it will bring to young children, so we will make it our number one priority over the next few months that the medicine is available across Europe.’
Trimedica Limited will be the exclusive distributor for the drug.
