Rafael Pharmaceuticals Inc. said its drug CPI-613 received the orphan drug designation in the EU to treat pancreatic cancer that has spread.
The tag, granted by the European Medicines Agency, is meant to incentivize the development of medicines for conditions that affect less than five in 10,000 people in the region. With the designation in hand, the medicine, which is also known as devimistat, will be eligible for fee reductions, market exclusivity and other benefits once approved.
CPI-613 is being studied across multiple trials in patients with pancreatic cancer, which is hard to diagnose at an early stage and leads to death within five years from the time it has been discovered.
The Newark, N.J.-based company's medicine is also designated as an orphan drug in the U.S. for multiple cancer types, including those of the pancreas.