Biopharmaceutical company J & D Pharmaceuticals LLC announced on Thursday that it has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its investigational therapy for the treatment of Hepatocellular Carcinoma (HCC), a rare and life-threatening disorder that is estimated to occur in approximately 73,000 individuals in the United States in 2025.

With currently approved medications, the amount of time extended in patients with HCC is only 2.5 months. There is a need for a safer and more effective medication for HCC, J & D Pharmaceuticals said.

Orphan Drug Designation provides incentives to encourage the development of treatments for rare diseases, including tax credits for qualified clinical testing, exemption from certain FDA fees, and the potential for seven years of market exclusivity upon regulatory approval.

J & D Pharmaceuticals is planning to advance its HCC programme into clinical development, and said that it will continue working closely with the FDA and the HCC community to accelerate progress toward delivering a novel treatment option to patients in need.