FDA Grants Fast Track Designation to Treatment for Systemic Sclerosis

The FDA has granted Fast Track Designation to a therapy for the treatment of systemic sclerosis (SSc), a severe form of scleroderma.

The designation was granted to Emerald Health Pharmaceuticals’ EHP-101, an oral formulation of a novel aminoquinone synthetic derivative of cannabidiol endowed with dual peroxisome proliferator-activated receptor gamma and cannabinoid receptor type 2 agonist activity.

According to Emerald Health, a phase 2 clinical study for SSc with EHP-101 is occurring in Australia, New Zealand, and the United States. In addition, EHP-101 previously received Orphan Drug designation in the United States, and in the European Union for the treatment of SSc.

SSc is a rare and autoimmune disease, causing fibrosis of the skin and internal organs, including small blood vessel damage in the skin and multiple organs in the body. The symptoms may vary for each person and could be life-threatening, depending on which parts of the body are affected and the extent of the disease.

REFERENCE

Emerald Health Pharmaceuticals Receives Fast Track Designation from US FDA for EHP-101 in the Treatment of Systemic Sclerosis. San Diego, CA; March 3, 2020: Emerald Health. https://www.globenewswire.com/news-release/2020/03/03/1994306/0/en/Emerald-Health-Pharmaceuticals-Receives-Fast-Track-Designation-from-US-FDA-for-EHP-101-in-the-Treatment-of-Systemic-Sclerosis.html. Accessed March 3, 2020.