J & D Pharmaceuticals LLC is thrilled to share that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to their investigational therapy, JD-004, for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). This rare genetic disorder impacts around 600,000 individuals in the United States, causing the progressive formation of fluid-filled cysts in the kidneys, often leading to kidney failure and the necessity for dialysis or transplantation. Despite being a prevalent inherited kidney condition, safe and effective treatment options are currently very limited.
Lenard Lichtenberger, PhD, Chief Scientific Officer of J & D Pharmaceuticals LLC, expressed, “Receiving Orphan Drug Designation is a significant milestone for J & D Pharmaceuticals. This designation highlights the critical need for innovative therapies for ADPKD patients and reinforces our dedication to developing solutions that can enhance the lives of those grappling with this challenging condition.”
The FDA’s Orphan Drug Designation program offers incentives to drive the development of treatments for rare diseases, including tax credits for qualified clinical testing, federal grant programs, exemption from specific FDA fees, and the potential for seven years of market exclusivity upon regulatory approval. J & D Pharmaceuticals is set to swiftly advance its ADPKD program into clinical development, collaborating closely with the FDA and the nephrology community to expedite progress in providing this groundbreaking anti-inflammatory treatment choice to patients in need. JD-004 has undergone safe testing in patients with osteoarthritis and rheumatoid arthritis.