CHMP backs Nova Laboratories' Mercaptopurine oral suspension for leukaemia 28/07/2011
An oral suspension of leukaemia medicine mercaptopurine has moved a key step closer to the European pharmaceutical market.
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).
It is intended for the treatment of acute lymphoblastic leukaemia in all adults, adolescents and children. Leicester-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 submitted, 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.
John Seaton, Financial and Commercial Director for Nova Laboratories, said it was an exciting time for the company and he was absolutely delighted that its novel medicine development and manufacturing expertise has been recognised.
“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,” he said.
“We are committed to developing childrens’ and adult medicines and this will be the first of many that Nova brings to market.”
The product will be exclusively distributed by Trimedica Limited. For all enquiries please contact: firstname.lastname@example.org or call Matt Jelley, Commercial Director, on 0044(0)755 752 7112.
For more information on Mercaptopurine: http://en.wikipedia.org/wiki/Mercaptopurine