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In another milestone, cannabinoid-based drug maker GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) said Monday the European regulatory agency has given the go-ahead for marketing its epilepsy drug Epidiolex in the region.
What To Know
GW Pharma said the European Commission has approved the marketing authorization for Epidiolex as an adjunctive therapy of seizures associated with Lennox-Gastaut syndrome, or LGS, or Dravet syndrome, or DS, in conjunction with clobazam, for treating patients two years of age and older.
In late July, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion, recommending approval of Epidiolex.
The approval allows the company to commercially launch the drug in all 28 countries of the EU, as well as in Norway, Iceland and Liechtenstein. The EC had predicated its decision on results from four randomized, controlled Phase 3 trials, which produced data from over 714 patients.
Why It's Important
LGS and DS are two rare forms of epilepsy with high morbidity and mortality rates. Most affected people have multiple seizures per day, exposing them to the risk of falls and injury.
"The approval of cannabidiol oral solution is an important milestone for patients and families whose lives are significantly impacted by these rare, complex and life-long forms of epilepsy," said Isabella Brambilla, Chairman, Dravet Syndrome European Federation.
Epidiolex, a CBD oral solution, was approved by the FDA in June 2018 for the treatment of seizures associated with LGS or DS in patients two years of age or older.
For the second quarter ended June 30, Epidiolex fetched sales of $68.4 million, with sales for the first half totaling $101.9 million.
In pre-market trading, GW Pharma shares traded higher by 4% to $134.10.
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