RXi drug secures ‘orphan’ status from FDA
A drug being developed by RXi Pharmaceuticals of Marlborough to treat patients with malignant melanoma has secured “orphan” status from the federal government, allowing RXi to seek more incentives to bring it to market, the company announced.
The drug, Samcyprone, is being developed to help prevent the skin-level spread of melanoma.
The designation from the U.S. Food and Drug Administration qualified RXi for several incentives, including seven years of market exclusivity after the drug's approval, tax credits for clinical research costs and reductions in application fees, RXi said in a statement.
The orphan designation is reserved for drugs that are used to treat rare diseases or conditions and whose development costs might not be adequately recovered through sales.
In a company statement released Friday, RXi President Geert Cauwenbergh called the FDA’s action an “important step” for patients who suffer from malignant melanoma.
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