We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
GW Pharma Gets EU Nod for Anti-Epileptic Drug Epidyolex
Read MoreHide Full Article
GW Pharmaceuticals plc announced that the European Commission (EC) has approved its anti- epileptic drug Epidyolex as an adjunct treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in conjunction with clobazam for patients aged two years or older.
The nod makes Epidyolex (cannabidiol oral solution) the first plant-derived cannabinoid prescription medicine to be approved by the European Medicines Agency (EMA). The drug is also the first and the only EMA-approved cannabidiol (CBD) medicine approved to treat LGS and Dravet syndrome, two severe and life-threatening forms of childhood-onset epilepsy.
In July 2019, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on Epidyolex, recommending its marketing authorization application for the given indication.
Epidyolex is marketed as Epidiolex in the United States for treating seizures associated with LGS or Dravet syndrome in patients aged two years and above.
The EU approval was based on data from four phase III studies, which evaluated Epidyolex in 714 patients with either LGS or Dravet syndrome. When added to other anti-epileptic therapies, Epidyolex significantly reduced the frequency of seizures in the given patient population.
Shares of GW Pharmaceuticals have rallied 29.9% so far this year compared the industry’s increase of 17.4%.
Epidiolex was approved in the United States in June 2018. The product became the first cannabis-derived medicine to gain an approval from the FDA for the treatment of LGS and Dravet syndrome in patients aged two years or older.
Epidiolex generated sales of $101.9 million in the first half of 2019. The drug has seen a strong uptake in sales and new patient enrollments since its launch.
In May this year, GW Pharmaceuticals announced positive top-line results from the phase III study evaluating Epidiolex for treating seizures associated with tuberous sclerosis complex (TSC). A supplemental new drug application for the same is expected to be filed in the fourth quarter of 2019.
We remind investors that the marijuana industry has a solid potential, especially after its legalization for recreational and medicinal use. Further, legalization of cannabis is likely to drive its commercial distribution and boost growth of companies operating in this space. Apart from GW Pharmaceuticals, companies, such as CannTrust Holdings Inc. , Cronos Group Inc. (CRON - Free Report) and Canopy Growth Corp. (CGC - Free Report) are all discovering, developing and manufacturing drugs from cannabis for various recreational and medicinal purposes.
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2018, while the S&P 500 gained +15.8%, five of our screens returned +38.0%, +61.3%, +61.6%, +68.1%, and +98.3%.
This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.
Image: Bigstock
GW Pharma Gets EU Nod for Anti-Epileptic Drug Epidyolex
GW Pharmaceuticals plc announced that the European Commission (EC) has approved its anti- epileptic drug Epidyolex as an adjunct treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in conjunction with clobazam for patients aged two years or older.
The nod makes Epidyolex (cannabidiol oral solution) the first plant-derived cannabinoid prescription medicine to be approved by the European Medicines Agency (EMA). The drug is also the first and the only EMA-approved cannabidiol (CBD) medicine approved to treat LGS and Dravet syndrome, two severe and life-threatening forms of childhood-onset epilepsy.
In July 2019, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on Epidyolex, recommending its marketing authorization application for the given indication.
Epidyolex is marketed as Epidiolex in the United States for treating seizures associated with LGS or Dravet syndrome in patients aged two years and above.
The EU approval was based on data from four phase III studies, which evaluated Epidyolex in 714 patients with either LGS or Dravet syndrome. When added to other anti-epileptic therapies, Epidyolex significantly reduced the frequency of seizures in the given patient population.
Shares of GW Pharmaceuticals have rallied 29.9% so far this year compared the industry’s increase of 17.4%.
Epidiolex was approved in the United States in June 2018. The product became the first cannabis-derived medicine to gain an approval from the FDA for the treatment of LGS and Dravet syndrome in patients aged two years or older.
Epidiolex generated sales of $101.9 million in the first half of 2019. The drug has seen a strong uptake in sales and new patient enrollments since its launch.
In May this year, GW Pharmaceuticals announced positive top-line results from the phase III study evaluating Epidiolex for treating seizures associated with tuberous sclerosis complex (TSC). A supplemental new drug application for the same is expected to be filed in the fourth quarter of 2019.
We remind investors that the marijuana industry has a solid potential, especially after its legalization for recreational and medicinal use. Further, legalization of cannabis is likely to drive its commercial distribution and boost growth of companies operating in this space. Apart from GW Pharmaceuticals, companies, such as CannTrust Holdings Inc. , Cronos Group Inc. (CRON - Free Report) and Canopy Growth Corp. (CGC - Free Report) are all discovering, developing and manufacturing drugs from cannabis for various recreational and medicinal purposes.
Zacks Rank
GW Pharmaceuticals currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2018, while the S&P 500 gained +15.8%, five of our screens returned +38.0%, +61.3%, +61.6%, +68.1%, and +98.3%.
This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.
See their latest picks free >>