EC approves its first plant-derived cannabis-based medicine
Epidyolex (cannabidiol) approved for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy.
The European Commission (EC) has approved the marketing authorisation for GW Pharmaceuticals' Epidyolex for use as adjunctive therapy of seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older. The approval paves the way for the launch of the medicine across Europe.
The approval of Epidyolex marks a significant milestone, offering patients and their families the first in a new class of epilepsy medicines and the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy,” said Justin Gover, GW’s CEO. “This approval is the culmination of many years of dedication and collaboration between GW, physicians and the epilepsy community. We believe patients and physicians deserve access to rigorously tested and evaluated cannabis-based medicines, manufactured to the highest standards and approved by medicines regulators, and we are delighted to be the first to offer this solution to the epilepsy community.”
The approval of cannabidiol oral solution is based on results from four randomised, controlled Phase III trials. These studies incorporate data from more than 714 patients with either LGS or Dravet syndrome, two rare forms of epilepsy with high morbidity and mortality rates, which place a significant burden on families and caregivers. Many patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at ongoing risk of falls and injury. Despite current anti-epileptic drug treatment, both of these severe forms of epilepsy remain highly treatment-resistant.
“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. “We are very happy that patients will now have access to a much-needed, new treatment option, and one routed through a rigorous clinical trials programme and licensed by the EMA.”
“LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy, with few patients achieving adequate seizure control,” said Professor Elinor Ben-Menachem, University of Goteborg, Sahlgren Academy and Hospital in Sweden. “The EMA approval of EPIDYOLEX will bring hope to patients and families, with the potential to better control seizures and improve quality of life.”
When added to other anti-epileptic therapies, Epidyolex significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome. The most common adverse reactions that occurred in patients treated with the medicine were somnolence, decreased appetite, diarrhoea, pyrexia, fatigue and vomiting. GW’s development programme represents the only well-controlled clinical evaluation of a cannabinoid medication for patients with LGS and Dravet syndrome.
GW’s cannabidiol oral solution was approved by the FDA in June 2018 under the trade name Epidiolex for the treatment of seizures associated with LGS or Dravet syndrome in patients 2 years of age or older.
The EC decision is valid in all 28 countries of the European Union, alongside Norway, Iceland and Liechtenstein.
Related News
-
News Eli Lilly gets ready to launch five new drugs in 2023
Eli Lilly, the American pharmaceutical company (IN, USA) are gearing up for a big year ahead, with hopes to launch five new drugs and capitalise on growing obesity and Alzheimer’s disease markets. -
News Amgen buys Horizon for $27.8 billion in bold step into the rare disease market
Amgen Inc buys pharmaceutical company Horizon Therapeutics in a multibillion-dollar deal, in hopes to capitalise on it's portfolio of drugs in the highly sort after rare disease market. -
News Pharma Supply Chain People Moves
The latest appointments and promotions across the pharmaceutical supply chain. -
News Merck to donate new Ebola vaccine to defend against outbreaks in Uganda
Pharmaceutical giant Merck has announced they will be speeding up the processing of a new vaccine against the latest strain of the Ebola virus, to be donated to a global non-profit organisation for distribution -
News CPHI Podcast Series: Driving innovation with pharmaceutical startups
The latest episode in the CPHI Podcast Series explores how startups are driving innovation by taking high-risk approaches and doing business with greater agility. -
News Greener and efficient processes: Quaternary Ammonium Salts
Quaternary Ammonium Salts play a crucial part in Organic Chemistry processes at many major industries. Discover why.
-
News Biosimilars save patients $11B annually, but barriers to adoption remain in US market
Biosimilars introduce competition into the biologics market, driving down prices and increasing patient access. -
News WHO recommends use of two monoclonal antibody treatments against Ebola
The health body recommended use of treatments by Regeneron and Ridgeback Bio
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance