Today, Biopharmaceutical company Alfacell Corp. is asking the Food and Drug Administration to grant its lead drug candidate, Onconase, orphan drug status. Onconase is aimed at treating malignant mesothelioma, a rare form of cancer where malignant cells are found in the chest, abdominal cavity lining or the lining around the heart. The drug is currently in its confirmatory phase 3b trial for the treatment of unresectable malignant mesothelioma.
The Food and Drug Administration's orphan-drug designation is for drugs that treat diseases affecting fewer than 200,000 people in the United States. If granted, the designation will give Onconase seven years of market exclusivity as a malignant mesothelioma treatment
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