Orphan drug status for Levulan, Vekacia, ARD-07

Levulan Photodynamic Therapy
On March 20, 2007, the U.S. Food and Drug Administration (FDA) granted orphan drug status to aminolevulinic acid in combination with photodynamic therapy (Levulan Photodynamic Therapy), made by DUSA Pharmaceuticals, Inc. This treatment is for esophageal dysplasia, meaning abnormal cell growth in the esophagus that puts individuals at high risk for cancer of the esophagus.

Vekacia
On May 4, 2007 the FDA granted orphan drug status to cyclosporine A (Vekacia), made by Novagali Pharma. This drug is for the treatment of vernal keratoconjunctivitis, a rare form of allergic conjunctivitis. In March 2006, the Committee for Orphan Medical Products, a division of the European Medicines Agency (EMEA), granted orphan drug designation in the European Union to Vekacia. If approved, Vekacia would be the first treatment for this disorder.

ARD-07
On May 14, 2007, the FDA granted orphan drug status to peptidomimetic analog of hexarelin (ARD-07), made by Ardana. ARD-07 will be used to diagnose growth hormone deficiency in adults.