Insys Therapeutics ( INSY ) announced that the FDA has granted orphan drug status to its pharmaceutical cannabidiol (CBD), for the treatment of glioblastoma multiforme (GBM). Glioblastoma multiforme is the most common and aggressive form of malignant primary brain tumor.
We note that the FDA grants orphan designation to candidates being developed to treat rare diseases/disorders (affecting less than 200,000 people in the U.S.). The status makes the candidate eligible for seven years of marketing exclusivity in the U.S. following approval. This designation also makes Insys eligible for certain other financial benefits for developing pharmaceutical CBD.
We remind investors that Insys already has orphan drug designation for pharmaceutical CBD for treating Dravet syndrome (a rare form of intractable epilepsy that commences in infancy) and Lennox-Gastaut syndrome (a rare form of pediatric epilepsy).
The company is evaluating the possibility of developing the candidate for several additional indications, which include adult epilepsy, chemotherapy-induced peripheral