Tengion of East Norriton, Pennsylvania, a company co-founded by Dr. Anthony Atala, has received orphan-drug designation from the FDA for the its Neo-Urinary Conduit, an autologous implant that helps “catalyze regeneration of native-like bladder tissue for bladder cancer patients requiring a urinary diversion following bladder removal.”
Orphan drug designation entitles Tengion to seven years of U.S. marketing exclusivity for the Neo-Urinary Conduit if and when it receives regulatory approval, as well as additional incentives in the form of tax credits for clinical research expenses and a waiver of the FDA’s application user fee. Orphan-drug status is granted by the FDA to promote the development of new therapies for medical conditions affecting fewer than 200,000 individuals in the United States.
Here’s a video demonstrating how the technology is applied:
Press release: Tengion Announces FDA Orphan-Drug Designation for Neo-Urinary Conduit …