Emerald Health Pharmaceuticals, a division of Emerald Health Sciences, which holds a public division through Emerald Health Therapeutics (TSXV:EMH), announced that it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for its drug candidate, EHP-102 treating Huntington’s disease.
As quoted in the press release:
”Having secured orphan designation for our lead product, EHP-101, a cannabidiol (CBD) derivative, for systemic scleroderma in the U.S. and Europe, we aim to repeat that accomplishment for EHP-102 for Huntington’s disease. The FDA’s granting of orphan designation for EHP-102 is a key step toward that goal,” said Jim DeMesa, MD, CEO of EHP. ”These are debilitating diseases that need new and more innovative treatments, and we look forward to getting our drug candidates into human studies.”
Huntington’s disease typically appears in the 30 – 50 year age range. It deteriorates patients’ physical and mental abilities to the extent that they are unable to care for themselves, and has no cure. A child of a parent with HD has a 50% chance of carrying the faulty gene. In the U.S., approximately 30,000 people are symptomatic and more than 200,000 are at risk of inheriting the disease (Huntington’s Disease Society of America).
The FDA grants Orphan Drug Designation status to drugs and biologics that treat rare diseases, defined as those affecting fewer than 200,000 people in the U.S. The FDA Office of Orphan Products Development evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and support their scientific development.