Pharmaceutical Business review

FDA grants orphan status to Dusa drug

Esophageal dysplasia occurs in some patients with Barrett’s esophagus, a leading cause of esophageal cancer. The incidence of esophageal cancer is one of the most rapidly growing in the US, with more than 11,000 new diagnoses each year. Patients diagnosed with high grade dysplasia are at high risk for developing esophageal cancer and currently have limited treatment options.

“We are pleased to receive orphan drug designation for Levulan” said Robert Doman, Dusa’s president and COO. “We believe that Levulan, in combination with our proprietary endoscopic light delivery system, is ideal for this significant unmet medical need and we are excited that it may someday provide patients at high risk of developing esophageal cancer with an effective and well tolerated therapeutic alternative.”

Photodynamic therapy (PDT) is a photochemical process that involves the interaction of a photosensitizer, light, and oxygen to selectively destroy malignant or certain benign, but rapidly growing cells. The procedure involves administration of a drug and subsequent illumination of the target cells with an appropriate light to activate the PDT process.