Clinigen Group and United Therapeutics Initiate Managed Access Program for UNITUXIN
The program, which will be managed by Idis MA, will enable individual adolescents and children as young as 12 months old with high risk neuroblastoma to receive UNITUXIN™ (dinutuximab) injection in specific countries where the drug has not yet been commercialized.
Neuroblastoma is the most common extracranial solid cancer in childhood and has the highest incidence in infancy, with approximately 1,500 patients in the European Union diagnosed each year, of whom 50% are classed as high risk.
UNITUXIN™ (dinutuximab) injection was granted Marketing Authorization by the European Commission in August 2015 for the treatment of high risk neuroblastoma in patients from 12 months to 17 years. These patients had previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). On 10 March 2015 UNITUXIN™ (dinutuximab) injection became the first therapy to be approved by the US Food and Drug Administration (FDA) for this indication.
Simon Estcourt, Managing Director, Idis Managed Access, Clinigen Group said: "Neuroblastoma is a devastating disease which seriously endangers young lives and where there are few treatment options available. As partners to United Therapeutics, we can leverage our global distribution network and regulatory expertise to deliver UNITUXIN™ injection to the physicians on behalf of their young patients wherever and whenever it is needed, fast."
Dr. Jay Watson, Pharm.D., Executive Vice President of Strategic Operations & Logistics for United Therapeutics, said: "We are very excited to partner with Idis Managed Access to help in the global distribution of UNITUXIN™ as a means to expand access for this important treatment in patients with neuroblastoma, prior to formal marketing authorization approval in those countries."
Access to UNITUXIN™ (dinutuximab) injection will be provided by Idis MA following a physician request for individual patients who meet the established eligibility criteria. Healthcare professionals can obtain details about the Managed Access program by calling +44 (0)1932 824 123 or via email at email@example.com