FDA Approves Intravenous Administration of Oncaspar
Enzon Announces FDA Approval of Intravenous Administration of Oncaspar
New Label Provides Clinicians with an Important New Option for Administering Oncaspar to Pediatric Patients
BRIDGEWATER, N.J., November 10, 2005 - Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling change for its pediatric oncology drug, Oncaspar. The new labeling allows for administration via the intravenous (IV) route. IV administration provides clinicians with an important new option that will potentially reduce the number of injections for pediatric cancer patients who require Oncaspar in their treatment regimen. Previously, Oncaspar's administration was limited to intramuscular administration, which involves injecting the drug directly into the muscle and is often painful to patients.
Oncaspar is a PEG-enhanced version of the naturally occurring enzyme L-asparaginase. L-asparaginase is an enzyme that depletes the amino acid asparagine, which certain leukemic cells are dependent upon for survival. Oncaspar was granted a marketing license by the U.S. Food and Drug Administration in February 1994 to treat patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment regimen, but have developed hypersensitivity to native forms of L-asparaginase. Through its proprietary PEGylation technology, Enzon designed Oncaspar to offer therapeutic advantages over unmodified L-asparaginase. In addition to reduced immunogenicity, Oncaspar provides a more convenient, patient-friendly dosing regimen that allows for administration every 14 days, versus twice weekly for unmodified L-asparaginase. Enzon's specialized oncology sales force markets Oncaspar in North America.
About 35,000 new cases of leukemia will be diagnosed in the United States during 2005. Of these about 4,000 will be acute lymphoblastic leukemia (also called acute lymphocytic leukemia or ALL). Although ALL is mainly a childhood leukemia, about one-third of new cases will occur in adults.
Souce: Enzon Pharmaceuticals, Inc.
Posted: November 2005