ICYMI: GW Pharmaceuticals Gets FDA Acceptance Letter for New Drug Review

A little more hope is given to individuals suffering from Lennox-Gastaut syndrome and Dravet syndrome as GW Pharmaceuticals shared the U.S. FDA will indeed be accepting their application for potential new treatments, reported Rare DR. The new drug application (NDA) was submitted in October, and this is the news needed to take another step forward. The FDA anticipates completing the review for the NDA by June 27th of this next year.
In the meantime, those with Lennox-Gastaut (LGS) and Dravet syndrome and their families have to wait. These syndromes are rare epileptic disorders that affect children. Symptoms from these disorders include consistent and intense seizures. To read more about LGS, click here, and to read more about Dravet syndrome, click here.
GW Pharmaceuticals developed a treatment and tested its effectiveness reducing monthly seizures to those affected by the disease. They were successful in decreasing seizures from about 12.4 to 5.9. Those who took the placebo barely noticed a decrease from 14.9 to 14.1.

Justin Gover, Chief Executive Officer of GW Pharmaceuticals is very pleased with the acceptance. He is excited to continue working with the FDA to finalize a hopefully successful treatment. While they are still far from a cure, this treatment could highly-reduced the intensity of both diseases, making patients far more comfortable in their day to day lives. Upon receiving the NDA acceptance letter, Gover also was pleased to read that the FDA will be holding a committee meeting very soon to discuss the future of their application. This is always good news to hear.

GW has a good history with the FDA, having previously been fast tracked for a designation that would benefit those with Dravet syndrome. Additionally, they are currently working on other treatments for LGS, Dravet, West syndrome and tuberous sclerosis complex. Clinical development for other seizure disorders are additionally being reviewed and are in Phase 3 trials.

GW has done a lot for rare diseases, and we can only hope that come June we get the news of approval to move forward with treatment for LGS and Dravet syndrome.


Share this post

Share on facebook
Share on google
Share on twitter
Share on linkedin
Share on pinterest
Share on print
Share on email
Close Menu