FDA grants orphan status to Clinuvel’s afamelanotide
NEW YORK The Food and Drug Administration has granted orphan drug status to Australia-based Clinuvel Pharmaceuticals’ drug for erythropoietic porphyries, afamelanotide.
The disease, which affects fair-skinned people, causes light sensitivity, severe pain, swelling and scarring. People with the disease must often stay indoors.
The FDA grants orphan status for drugs to treat rare illnesses.