U.S. markets open in 7 hours 53 minutes
  • S&P Futures

    3,823.50
    -4.50 (-0.12%)
     
  • Dow Futures

    31,296.00
    -75.00 (-0.24%)
     
  • Nasdaq Futures

    12,766.75
    -65.00 (-0.51%)
     
  • Russell 2000 Futures

    2,181.70
    -18.30 (-0.83%)
     
  • Crude Oil

    62.90
    -0.63 (-0.99%)
     
  • Gold

    1,761.20
    -14.20 (-0.80%)
     
  • Silver

    26.97
    -0.72 (-2.60%)
     
  • EUR/USD

    1.2157
    -0.0030 (-0.24%)
     
  • 10-Yr Bond

    1.5180
    0.0000 (0.00%)
     
  • Vix

    28.89
    +7.55 (+35.38%)
     
  • GBP/USD

    1.3929
    -0.0084 (-0.60%)
     
  • USD/JPY

    106.1730
    -0.0570 (-0.05%)
     
  • BTC-USD

    46,131.91
    -3,799.97 (-7.61%)
     
  • CMC Crypto 200

    919.14
    -14.00 (-1.50%)
     
  • FTSE 100

    6,651.96
    -7.01 (-0.11%)
     
  • Nikkei 225

    28,966.01
    -1,202.26 (-3.99%)
     

GW Pharma's CBD Seizure Drug Epidiolex Approved In Europe As Adjunctive Therapy

  • Oops!
    Something went wrong.
    Please try again later.
Shanthi Rexaline
  • Oops!
    Something went wrong.
    Please try again later.

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.

Related Links:

The Week Ahead In Biotech: Spotlight On ESMO Conference

Axsome Shares Flirt With Record High: How Much Upside Is Left?

See more from Benzinga

© 2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.