FDA Grants Orphan Drug Status to Amatuximab for Malignant Pleural Mesothelioma
Morphotek, a subsidiary of Eisai, announced that the FDA has granted orphan drug designation to its investigational cancer drug, amatuximab (MORAb-009) for the treatment of malignant pleural mesothelioma, the most common form of mesothelioma. Amatuximab is an investigational chimeric IgG1 antibody that targets a cell surface glycoprotein, mesothelin, which is over-expressed in a number of cancers.
The Orphan Drug Act (ODA) allows the FDA to grant orphan status to a drug which has the potential for the safe and effective treatment, diagnosis, or prevention of a rare disease/disorder that affects <200,000 people in the United States. Under the ODA, orphan designation qualifies the sponsor of the product for certain incentives, such as tax credits, prescription drug user fee waivers for the development product, and a seven year period of marketing exclusivity from the date of approval.