European Commission Approves GW Pharmaceuticals Plc (NASDAQ:GWPH)’s Epidyolex To Treat Seizures In Patients With TSC

European Commission approved Epidyolex of GW Pharmaceuticals Plc (NASDAQ:GWPH) to cure seizures associated with TSC patients aged two years and above. GW Pharmaceuticals will use EC approval for the expanded introduction of Epidyolex in Europe. 

EC approved EPIDYOLEX after considering the positive data from Phase 3 efficacy and safety study that examined 25 mg/kg/day of cannabidiol of GW Pharmaceuticals. The drug achieved the primary endpoint in reducing the frequency of seizures compared to the baseline of CBD against placebo. No safety risks of the drug are noticed in the clinical trial of the drug. 

Epidyolex treats debilitating diseases

CEO of GW Pharmaceuticals, Justin Gover said the EC nod for its Epidyolex helps the patients to treat their debilitating disease. The approval of EC is on the backdrop of dedicated efforts of patient communities, physicians, and the teams of GW Pharmaceuticals. 

The company will work with the member states in Europe and ensure the availability of Epidyolex quickly to the patients’ cure. 

CMO of GW Pharmaceuticals, Volker Knappertz, said the company is thrilled to receive the approval of EC for its innovative drug formulation – Epidyolex. The company will put in significant efforts to offer the benefits of Epidyolex to the communities and improve their quality of life. 

Physicians can use this drug as an alternative to manage seizures associated with patients suffering from TSC. It has the potential to cure thousands of patients, who are not responding to traditional care. 

The coordinator for ERN (Rare and Complex Epilepsies ERN EpiCARE), Alexis Arzimanoglou, said EPIDYOLEX demonstrated its safety and efficacy profile in curing seizures related to TSC. Therefore, it is an important development for those who need immediate treatment. 

The US FDA approved EPIDYOLEX, which is derived from cannabis, as the first prescription drug for use in the United States. It is an oral solution comprising purified CBD. The drug offers treatment for seizures related to LGS (Lennox-Gastaut syndrome), TSC (Tuberous Sclerosis Complex) or Dravet syndrome in patients aged one year or older. 

Jazz Pharmaceuticals Plc receives nod to acquire GW Pharmaceuticals

Jazz Pharmaceuticals Plc (NASDAQ:JAZZ) received the nod of shareholders of GW Pharmaceuticals to acquire the latter by its subsidiary on April 23, 2021. It also received regulatory approvals in favor of the deal. However, the deal is subject to the final verdict of the court (High Court of Justice of England and Wales).