One orphan drug designation has been granted for diffuse large B-cell lymphoma and the other one for the treatment of follicular lymphoma. Reviroc is under development for the elimination of cancer cells from an autologous graft in bone marrow transplantations for end-stage blood cancer patients.
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 US. 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.
Manja Bouman, CEO of Kiadis Pharma, said: “This is an important strategic milestone in the development of Reviroc and we are very pleased with the orphan drug designations received from the FDA.”