EU Approves First Childhood Neuroblastoma Drug

11.05.2017 -

UK specialty pharmaceutical company EUSA Pharma has won European approval for its monoclonal antibody dinutuximab beta to treat children over the age of 12 months with neuroblastoma, a rare cancer.

The approval is the first in Europe for high-risk neuroblastoma, which predominantly affects children under five years and spreads very quickly. Around 1,200 children are diagnosed in Europe every year with the disease.

The decision means that the drug can now be made available across Europe, improving access for thousands of children and their families to this new treatment, with proven improved survival rates, noted Steve Richards, CEO of the neuroblastoma charity Solving Kids’ Cancer Europe.

“The next challenge will be for EUSA Pharma to engage with relevant access bodies throughout Europe, including NICE (the UK National Institute for Health and Care Excellence) in the UK, to ensure timely review through the new drugs processes and secure access to this medicine for patients. The young innocent victims of this cruel and devastating disease deserve nothing less,” Richards commented

EUSA, which acquired exclusive global commercialization rights to the drug from Austrian biotech firm Apeiron Biologics in October last year, said it also expects to file for approvals in the US and Japan during 2017.