EMA grants orphan drug designation to Epidiolex® from GW Pharmaceuticals
Release Date: 07-Apr-2017
GW Pharmaceuticals has announced that European Medicine Agency has granted orphan drug designation to its leading product candidate, Epidiolexandreg; (cannabidiol or CBD) for effective treatment of the treatment of Lennox-Gastaut Syndrome (LGS), treatment-resistant, debilitating childhood-onset epilepsy. Additionally, the investigational drug has received orphan drug status in the treatment of LGS, Dravet syndrome, Tuberous Sclerosis Complex, and Infantile Spasms, each of which are severe infantile-onset, drug-resistant epilepsy syndromes.
The EMA grants an orphan drug designation to promote the development of products that demonstrate promise of significant benefit for the treatment of rare diseases. Products receiving orphan drug designation are eligible to receive various regulatory and economic benefits, including 10 years of market exclusivity in the EU.
“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
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