Morphotek Inc., a subsidiary of Eisai Inc., announced that the United States Food and Drug Administration or 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, which accounts for around 2,500 cases a year in the United States. This disease affects the pleura, which is the thin balloon shaped lining of the lungs.
The Orphan Drug Act (ODA) allows 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 fewer than 200,000 people in the United States.
Amatuximab (MORAb-009) is an investigational chimeric IgG1 antibody that targets a cell surface glycoprotein, mesothelin, which is over-expressed in a number of cancers.
by RTTNews Staff Writer
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