Afamelanotide (Clinuvel CUV1647) gets orphan drug status in the US

Afamelanotide (Clinuvel CUV1647) gets orphan drug status in the US

Clinuvel Pharmaceuticals has announced that they have been granted orphan-drug status by the FDA to treat the skin condition erythropoietic porphyrias. Orphan drug status is granted to new drugs that treat rare conditions and is used as an instrument to obtain accelerated review by the FDA. The FDA allows tax reductions and market exclusivity for orphan drugs to encourage otherwise un-profitable drugs targeting rare conditions to be developed.

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