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news.Tengion has said that the European Medicines Agency and the European Commission have formally designated company's autologous urothelial and smooth muscle cells, the Neo-Bladder Augment, as an orphan medicinal product for the treatment of spina bifida.
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This orphan designation qualifies the company and it’s 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 designation also enables the Neo-Bladder Augment to qualify for 10 years of marketing exclusivity in the EU upon marketing approval.
In accordance with directives set forth by the European Commission, EMEA’s Committee for Orphan Medicinal Products (COMP) agreed that company’s Autologous Neo-Bladder Construct meets the criteria for being designated as an EU Orphan Medicinal Product, for the treatment of spina bifida.
Steven Nichtberger, president and CEO of Tengion, said: “We are extremely pleased that EMEA and the European Commission has recognized the Neo-Bladder Augment’s potential to significantly improve the treatment of neurogenic bladder in spina bifida patients, a critically underserved patient population.”