This orphan medicinal product designation qualifies Tengion and its Neo-Bladder augment for European Medicines Agency (EMEA) regulatory incentives, including eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees. Orphan product designation also enables the Neo-Bladder Augment to qualify for 10 years of European marketing exclusivity upon marketing approval.
Although satisfactory methods of treatment for neurogenic bladder have been authorized by EMEA, Tengion has said that its Neo-Bladder Augment may provide significant clinical benefit to those spinal cord injury patients who suffer from neurogenic bladder and warrant surgical intervention for their condition.
Tengion previously announced that its Neo-Bladder Augment was granted EMEA and the European Commission orphan designation for the treatment of neurogenic bladder in spina bifida patients.
Steven Nichtberger, president and CEO of Tengion, said: “We are extremely pleased that EMEA and the European Commission have further recognized the Neo-Bladder Augment’s potential to significantly improve the treatment of neurogenic bladder, in this case in patients with spinal cord injury. We look forward to continuing to work with the EMEA, as well as with the FDA, to move our neo-organs through the respective regulatory pathways.”