European Medicines Agency (EMEA) Grants Orphan Drug Status for the
Treatment of Spina Bifida
EAST NORRITON, Pa., April 1 /PRNewswire/ -- Tengion Inc. announced today that the European Medicines Agency (EMEA) and the European Commission (EC) have formally designated Tengion's autologous urothelial and smooth muscle cells -- the Neo-Bladder Augment(TM) -- as an Orphan Medicinal Product for the treatment of spina bifida.
This Orphan Medicinal Product Designation qualifies Tengion and its Neo- Bladder Augment for 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 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 Tengion's Autologous Neo-Bladder Construct meets the criteria for being designated as an EU Orphan Medicinal Product, for the treatment of spina bifida. Spina bifida is a debilitating illness that frequently results in neurogenic bladder. Although satisfactory methods of treatment for the neurogenic bladder have been authorized by EMEA, justifications have been provided that the Neo- Bladder Augment may be of significant clinical benefit to those patients with spina bifida who suffer from neurogenic bladder and warrant surgical intervention for their condition.
"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," said Steven Nichtberger, M.D., President
and Chief Executive Officer of Tengion. "We look forward to continuing to
work with the EMEA, as we are with the U.S. Food and Drug Administr
|SOURCE Tengion Inc.|
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