Emerald’s Scleroderma Therapy Wins Orphan Drug Status in Europe

The European Medicines Agency has granted orphan drug designation to Emerald Health Pharmaceuticals’  lead cannabis-based product for treating systemic scleroderma.

EHP-101 is derived from cannabidiol, a chemical found in the cannabis plant. The therapy activates the cell-surface receptors PPARγ and CB2, which in turn activate cell signaling pathways that can help  people with tissue-scarring conditions, multiple sclerosis and other diseases. The signals prevent nerve cell inflammation, deterioration of the myelin coating that protects nerve cells, and tissue scarring, or fibrosis.

European regulators grant orphan drug status to promising treatments for rare diseases. The designation provides companies with a number of incentives to continue developing the treatments. These include reduced regulatory-review-related fees, European Commission funding for clinical trials, and 10 years of market exclusivity if a drug is approved.

Systemic scleroderma is a rare and chronic autoimmune disease that leads to fibrosis of the skin and internal organs. This involves tissue becoming

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