- Only anti-GD2 monoclonal antibody approved in the European Union -
- Expedited approval based on data from multiple clinical trials conducted across Europe -
- Approval for marketing of Dinutuximab beta in all 28 member states -
EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, today announced that the European Commission has approved Dinutuximab beta for the treatment of patients with high-risk neuroblastoma. Dinutuximab beta is the only anti-GD2 monoclonal antibody approved in the European Union (EU). EUSA Pharma will begin commercialising Dinutuximab beta across the EU immediately.
Dinutuximab beta, originally developed by the Vienna-based biotech company Apeiron Biologics, was previously available in Europe under a managed access program, and following the positive CHMP opinion issued in March 2017 was granted expedited EU approval. Dinutuximab beta forms a core element of the treatment guidelines for high-risk neuroblastoma. The marketing authorization is based on data developed from multiple clinical trials conducted across Europe that included over 1,000 patients receiving Dinutuximab beta.
Lee Morley,EUSA Pharma's Chief Executive Officer, said,"We are delighted with thisexpedited EU approvalforDinutuximab betaas itprovidesan important new therapeutic option for childrenwith high-risk neuroblastomawho currently have limitedtreatmentchoices.Neuroblastoma is a devastating disease that is responsible for up to 10% of childhood tumors, andEUSA is workinghard to bring this life-saving therapy to children around the world.As part of this mission we plan to launchDinutuximab beta immediately acrossthe EUwith our own team. In parallel we willfile Dinutuximab beta with the FDAfor approval in the United States as well as work with selected partners in other territories to secure access to Dinutuximab beta for patients worldwide."
About Dinutuximab beta and neuroblastoma
Neuroblastoma is an orphan oncology condition with significant unmet medical need. It accounts for up to 10% of childhood tumors and affects approximately 1,200 children in Europe each year. Dinutuximab beta has been used extensively across Europe under a managed access scheme and is included in a number of treatment protocols for high-risk neuroblastoma.
Dinutuximab beta is an anti-GD2 monoclonal antibody that significantly improves event-free and overall survival in children with high- risk neuroblastoma, with a favorable safety profile compared with other immunotherapies. Dinutuximab beta forms an important part of treatment regimens for high-risk neuroblastoma and its novel features offer the potential for further development to expand its current role. Dinutuximab beta has orphan drug designation in the US, and EUSA plans to file the product for approval in the United States in 2017.
Dinutuximab beta is approved in Europe for use in children aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma, with or without residual disease. In patients with previous relapsed / refractory disease and in patients who have not achieved a complete response after first line therapy, Dinutuximab beta should be combined with interleukin-2 (IL-2). Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company with commercial operations in the US and Europe, and a wider distribution network in approximately 40 further countries. Currently, EUSA has a broad portfolio of approved and named-patient specialty hospital products, which the company has ambitious plans to expand through acquisition and in-licensing. EUSA is led by an experienced management team with a strong record of building successful specialty pharmaceutical companies, and is supported by significant funding raised from leading life science investor Essex Woodlands.
In addition to Dinutuximab beta, EUSA Pharma's products include: Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy; Collatamp®, a gentamicin-collagen implant licensed either in hemostasis or for the prevention and treatment of surgical site infection; Custodiol® solution for use in the preservation of organs for transplantation; Fomepizole® for the treatment of ethylene glycol poisoning; and Xenazine® for the treatment of abnormal movements associated with Huntington's chorea and hemiballismus. EUSA also has exclusive European, Latin American, North and South African and selected Middle East and Asian rights to tivozanib, which is currently under review by EMA for the treatment of advanced renal cell carcinoma. For more information visit http://www.eusapharma.com.
SOURCE EUSA Pharma
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