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GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) Releases An Update On NDA Filing Of Epidiolex®

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GW Pharmaceuticals PLC- ADR

GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) along with its subsidiary Greenwich Biosciences, reported that it has completed the rolling filing of a NDA to the U.S. FDA for Epidiolex® as adjunctive treatment of seizures related with Dravet syndrome and Lennox-Gastaut syndrome (LGS), two highly treatment-resistant types of childhood-onset epilepsy.

The details

GW Pharmaceuticals has obtained Orphan Drug and Rare Pediatric Disease Designations from the FDA for Epidiolex targeting both Dravet and LGS syndrome. In addition, the company has obtained Fast Track status from the FDA for Epidiolex targeting Dravet syndrome.

Justin Gover, the CEO of GW Pharmaceuticals, expressed that the fling of the Epidiolex NDA is a vital milestone for patients with Dravet and LGS syndrome in that a prospective new treatment alternative is within sight for these extremely tough to treat and devastating conditions. On behalf of these patients, GW employees as well as clinicians, who have supported the Epidiolex plan, they are delighted to submit this promising treatment for FDA assessment and they look forward to coordinating with the FDA throughout the review procedure.

This regulatory filing is a demonstration of GW Pharmaceuticals’ commitment to advancing unique CBD-based treatments that have the prospect to resolve significant unmet medical needs. The New Drug Application for Epidiolex is supported by report from three Phase 3 efficacy and safety trials, each of which achieved their primary endpoint. As per the data, the drug was generally well tolerated in these three trials.

The NDA comprises safety data on around 1,500 patients, with about 400 patients on continuous treatment for over a year. Beyond pivotal efficacy and safety data, the NDA comprises a comprehensive clinical pharmacology, toxicology and pre-clinical package. The CMC segment of the NDA incorporates the firm’s newly expanded UK manufacturing facilities. GW Pharmaceuticals intends to submit a Marketing Authorization Application in Europe for Epidiolex in the imminent future.


 

 

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