BRI wins FDA orphan drug designation for brain cancer therapy

The orphan drug designation, as granted by the FDA’s Office of Orphan Products Development, was designed to encourage clinical development of products for use in rare diseases or conditions, usually defined as affecting fewer than 200,000 people in the US.

The orphan drug designation provides an economic incentive that stimulates the development of new products in the oncology field and allows for seven years of market exclusivity upon final FDA approval, as well as clinical study and R&D support, reduction in regulatory fees and potential tax credits.

Stanislaw Burzynski, chairman and CEO of Burzynski Research Institute (BRI), said: We are encouraged by the FDA’s action. Initially, BRI sought orphan drug designation for ANP in optic pathway glioma in children, a much narrower indication involving a smaller segment of tumors.

However, the FDA extended orphan drug designation to all gliomas, a recognition we believe underlies the broad potential of anitneoplaston therapy for the treatment of patients with cancer of the brain and nervous system. There is now even more motivation for us to evaluate our therapy as an innovative and efficacious choice in a treatment spectrum where disease management options are still quite limited.