GSK’s Atriance gets positive EMEA result

The European Medicines Agency (EMEA) has given a positive opinion to GlaxoSmithKline’s (GSK’s) Atriance (nelarabine solution for infusion) as a therapy for T-cell acute lymphoblastic leukaemia.

Used for administering care to patients when the disease has not responded to treatment with at least two chemotherapy regimens, the drug was also given a positive result for those whose treatment has relapsed.

The European Commission will now consider Nelarabine for final marketing approval.

“Nelarabine may offer some patients the chance to go on to have potentially curative treatment, such as a stem cell transplant, so we are delighted that nelarabine has been granted a positive opinion from the EMEA,” said Paolo Paoletti, senior vice-president and global head of oncology research and development at GSK.

Mr Paoletti said the group was “immensely proud” of the development of the orphan drug used to treat “such a rare disease”.

“It is an excellent example of our long-term commitment to improving the lives of patients through our ongoing investment in research and development,” he added.

In June 2005, nelarabine received EMEA orphan drug status, while in the US, where it is marketed as Arranon, it has held orphan drug status since December 2003. It was granted Food and Drug Administration approval in 2005.

Last week, GSK announced plans to launch five new oncology treatments in the next three years.