FDA GRANTS ORPHAN DRUG STATUS TO PANCREATIC CANCER VACCINE

The FDA has given orphan drug status to Pharmexa for the peptide vaccine GV1001 for the treatment of pancreatic cancer. Orphan drug status is granted to drugs aimed at diseases affecting fewer than 200,000 people in the United States.

Orphan drug status provides opportunities for a closer dialogue with the health authorities through the development process, as well as seven years of market exclusivity following drug approval. GV1001 already has orphan drug status in Europe for the same indication.