The orphan drug designation provides for an accelerated review process, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the US after product approval.
Rhitol has completed a multicenter Phase I/II study for patients with severe steroid resistant chronic graft versus host disease. A Phase III study is anticipated to start in 2008.
Manja Bouman, CEO of Kiadis Pharma, said: “The decision by the FDA to grant Rhitol orphan drug designation in this area of blood cancer with unmet medical need advances our efforts to develop an innovative treatment.”