Seattle Genetics Inc announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its product candidate SGN-30 for patients with Hodgkin's disease.
SGN-30 is a monoclonal antibody that is in an ongoing phase I/II clinical trial for the treatment of CD30-positive hematologic malignancies, including Hodgkin's disease, anaplastic large cell lymphoma and other types of lymphomas.
"We are encouraged by the data seen in our clinical trials of SGN-30 and by its potential as a treatment for patients with Hodgkin's disease," commented Clay B. Siegall, President and Chief Executive Officer of Seattle Genetics. "The FDA's orphan drug designation further strengthens our SGN-30 program by offering several important clinical development and commercialization benefits."
The Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States. Orphan drug designation, granted by the FDA's Office of Orphan Products Development, provides Seattle Genetics with a number of potential benefits for SGN-30. Included are the opportunity to obtain grant funding from the U.S. government to defray costs of clinical trial expenses, tax credits for clinical research expenses, potential waiver of the FDA's application user fee and seven years of marketing exclusivity in the event of market approval.