EC approves its first plant-derived cannabis-based medicine

24 Sep 2019

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.

EC approves its first plant-derived cannabis-based medicine

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.

Read More

Related news

Integrating glucose sensing and insulin delivery technologies

Integrating glucose sensing and insulin delivery technologies

18 Sep 2019

Collaboration aims to provide a connected device experience for millions of people living with diabetes using insulin.

Read more 
Drivers behind Saudi Arabia’s forecast 10.74 $billion 2022 market

Drivers behind Saudi Arabia’s forecast 10.74 $billion 2022 market

9 Sep 2019

Growing population, increase in non-communicable diseases and major investment in new hospitals, clinics and treatments driving growth.

Read more 
China relaxes import regulations to improve access and availability of affordable medicines

China relaxes import regulations to improve access and availability of affordable medicines

3 Sep 2019

The potential for generics to support the healthcare needs of China is significant.

Read more 
Exciting new vaccine targets killer disease TB

Exciting new vaccine targets killer disease TB

28 Aug 2019

Australian researchers produce early-stage vaccine which is inhaled into the lungs.

Read more 
Switzerland overtakes Germany as Europe’s biggest drug delivery innovator

Switzerland overtakes Germany as Europe’s biggest drug delivery innovator

16 Aug 2019

Pipeline of new drugs has helped drive increased innovation in packaging and drug delivery devices.

Read more 
How real-world data can revolutionise drug development

How real-world data can revolutionise drug development

9 Aug 2019

Utilising the current data environment and its data pools for the benefit of advancing research.

Read more 
Colorcon to incorporate TruTag's edible 'optical barcodes' in tablet film coatings

Colorcon to incorporate TruTag's edible 'optical barcodes' in tablet film coatings

6 Aug 2019

The benefits of this innovation include the ability to instantly and unequivocally authenticate products when suspect events.

Read more 
Mylan and Pfizer create new global pharma company

Mylan and Pfizer create new global pharma company

29 Jul 2019

The transaction will allow the new company to expand the geographic reach of Mylan's existing broad product portfolio and future pipeline.

Read more 
GSK opens new continuous manufacturing facilities in Singapore

GSK opens new continuous manufacturing facilities in Singapore

11 Jul 2019

Opening of continuous manufacturing facilities and expansion of production building will boost capabilities to accelerate the supply of new breakthrough medicines to patients globally.

Read more 
Catalent extends global commercial spray drying capabilities in Europe

Catalent extends global commercial spray drying capabilities in Europe

9 Jul 2019

Company's customers to have immediate access to Niro PSD2 and PSD4 spray driers, which are supported by dedicated clean area facilities for both solvent and aqueous processing of potent or non-potent drug formulations.

Read more