The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the orphan medicine, Mercaptopurine Nova Laboratories (mercaptopurine monohydrate), which is intended for the treatment of acute lymphoblastic leukaemia in all adults, adolescents and children.
The UK-based Nova Laboratories has formulated the medicine as a suspension, which provides improved accuracy and – especially when used in small children – ease of administration and more flexible and consistent dosing.
Development of age-appropriate formulation to treat this disease was identified as a priority research area by the EMA’s Paediatric Committee and Nova has spent more than two years on the project.
The CHMP, on the basis of quality, safety and efficacy data, considered there was a favourable benefit to risk balance for Mercaptopurine Nova Laboratories and therefore recommended the granting of a Europe-wide licence, subject to final ratification.
“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,” said John Seaton, Financial and Commercial Director for Nova Laboratories.
“We are committed to developing children’s and adult medicines and this will be the first of many that Nova brings to market.”