APEIRON Biologics has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of dinutuximab beta (ch14.18/CHO; APN311) for immunotherapy of high risk neuroblastoma.
Dinutuximab beta has been generated and profiled by European academic institutions originating at the Clinical Cancer Research Institute in Vienna (St. Anna Children’s Hospital), initiated by Prof. Ladenstein. The development was extended to multiple clinical trials across Europe and abroad, performed by the SIOPEN neuroblastoma study group and the German group at the University Children’s Hospital Greifswald led by Prof. Lode. In 2011, Apeiron and SIOPEN joined forces and Apeiron took over the lead for commercialization.
More than 1,000 patients have been treated and the results served as basis for Marketing Authorization Application (MAA) in the EU in 2015.
In September 2016, EUSA Pharma acquired an exclusive license to the global commercial rights to dinutuximab beta.
Based on the CHMP’s opinion published on March 24*), the European Commission within two months will issue a formal decision on the approval of dinutuximab beta, which is indicated for use in children aged 12 months and above with high risk neuroblastoma who have achieved a complete or partial response to prior therapy and those with a history of relapsed or refractory disease.
Dr. Hans Loibner, Apeiron’s Chief Executive Officer, said, “We are delighted with the CHMP positive opinion for approval of dinutuximab beta for immunotherapy of high risk neuroblastoma, an area of significant unmet medical need. We regard this as key step in the successful development of our company.” Dr. Oliver Mutschlechner, Apeiron’s VP Regulatory Affairs, added, “This was a complex but highly rewarding collaborative effort over several years between academic institutions and support companies**), coordinated and led by a dedicated group at Apeiron.”
Lee Morley, EUSA Pharma’s Chief Executive Officer, said, “This positive CHMP opinion is an important milestone for EUSA as we work to bring dinutuximab beta to children suffering from the high risk form of the devastating disease, neuroblastoma. Following this positive opinion in Europe, as next step we plan to submit dinutuximab beta for approval in the United States.“
**) Key external support provided by Granzer Regulatory Consulting & Services (www.granzer.biz/)