Biopharmaceutical company Kiadis Pharma announced today that the US Food and Drug Administration (FDA) has granted its product Rhitol orphan drug designation for the treatment of chronic Graft versus Host Disease (GvHD).
This complication of allogeneic bone marrow transplantation is highly debilitating and can become life threatening when the patient is unresponsive to steroid treatment.
Rhitol has completed a multicentre phase I/II study for patients with severe steroid resistant chronic GvHD. A phase III study is anticipated to start in this year.
“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” says Dr Manja Bouman, Chief Executive Officer of Kiadis Pharma.
The FDA’s orphan drug designation is reserved for new therapies being developed to treat diseases or conditions that affect fewer than 200,000 people in the United States.
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 United States after product approval.