Halozyme Therapeutics, Inc. announced on October 3, 2014, that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for PEGylated recombinant human hyaluronidase (PEGPH20) for the treatment of pancreatic cancer. The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. Halozyme is currently investigating PEGPH20 in a Phase 2 study in combination with gemcitabine and nab-paclitaxel (ABRAXANE®) in metastatic pancreatic cancer.
The FDA's Orphan Drug program provides orphan status to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. This designation provides eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.