The biotechnology firm’s Neo-Urinary Conduit is indicated as a treatment for bladder dysfunction requiring incontinent urinary diversion.
Orphan drug designation offers Tengion seven years of US marketing exclusivity for the Neo-Urinary Conduit if and when it receives regulatory approval.
Tengion chief medical officer Sunita Sheth said this designation is another important step in advancing the development of the Neo-Urinary Conduit, their lead clinical product candidate, currently being studied in patients with bladder cancer.