July 29, 2008
Ikaria Wins Orphan Designation for Inhaled Carbon Monoxide
Ikaria Holdings has announced that the FDA has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and severity of delayed graft function in patients undergoing solid organ transplantation.
Orphan drug designation provides an accelerated FDA review process, tax advantages and a seven-year period of market exclusivity in the US upon product approval.
Ikaria is currently conducting a single-blind, placebo controlled, dose-escalating Phase II study of inhaled carbon monoxide in patients receiving renal transplants.
The primary endpoint of the study is to evaluate the safety and tolerability of increasing carbon monoxide dose levels when administered as an inhaled gas to kidney transplant patients over the course of one hour in an acute hospital setting. The study was initiated in August 2007 and is currently enrolling patients.
Ralf Rosskamp, executive vice president of R&D at Ikaria, said: "The designation of orphan drug status is a significant step that will greatly facilitate the development of inhaled carbon monoxide as a potential treatment for delayed graft function in solid organ transplants."