FDA grants Tengion Orphan Drug designation
Tengion, based in East Norriton, Penn., said the FDA has granted Orphan Drug designation to the company's Neo-Urinary Conduit, for treatment of bladder dysfunction requiring incontinent urinary diversion.
"This designation is another important step in advancing the development of our Neo-Urinary Conduit, our lead clinical product candidate, currently being studied in patients with bladder cancer," said Sunita Sheth, M.D., Chief Medical Officer of Tengion.
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 U.S.