FDA declines to grant Levulan PDT Orphan Designation: DUSA Pharmaceuticals

Aug 7 2010

DUSA Pharmaceuticals, Inc.^® (Nasdaq: DUSA) reported today that on the afternoon of August 5, 2010 the U.S. Food and Drug Administration (FDA) notified DUSA that it has not granted Orphan Drug Designation for the use of Levulan^® (aminolevulinic acid HCl) Photodynamic Therapy (PDT) for the prevention of cutaneous squamous cell carcinomas (SCCs) in patients who have a proven history of multiple localized cutaneous SCCs over a 12 month period.  The FDA acknowledged that cutaneous SCC is a serious problem in patients at high risk for developing SCCs, such as solid organ transplant recipients (SOTRs), and that aminolevulinic acid would be a potential preventative therapy in these patients.  However, the FDA also stated that they believe there are other factors which place patients at high risk of developing SCCs that should be included in determining the target population.  To be eligible for Orphan Drug Designation, the drug must target a disease that affects fewer than 200,000 patients in the United States.  

"We believe that we appropriately identified the target population and are disappointed that the FDA has declined to grant Levulan^® PDT Orphan Designation for this indication.  DUSA feels that prevention of SCCs in this patient population would represent a significant advance in the management of these high risk patients," said Robert Doman, DUSA's President and Chief Executive Officer. "Without the regulatory protection and development opportunities that Orphan Drug Designation affords our resources are better utilized in other areas; therefore, we plan to close out our SOTR pilot clinical trial program over the next few months."  

SOURCE DUSA Pharmaceuticals, Inc.