Chasing Markets | GW Pharmaceuticals Receives FDA Approval for Cannabinoid Prescription Medicine

GW Pharmaceuticals plc GWPH a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics from its patented cannabinoid product platform, with its US subsidiary Greenwich Biosciences, announced on 25 Jun The US Food and Drug Administration (FDA) has approved the oral solution EPIDIOLEX® (cannabidiol) for the treatment of Lennox-Gastaut syndrome (LGS) or Dravet syndrome seizures in two-year-old patients or more.

"The approval of EPIDIOLEX is a landmark milestone, offering patients and their families the first and only FDA-approved drug to treat two severe epilepsies of childhood," he said. Justin Gover, General Manager of GW. "This endorsement is the culmination of GW's many years of partnership with patients, their families, and the physicians in the epilepsy community to develop a much-needed, innovative drug that will soon have access to a cannabinoid drug that has been the subject of extensive studies. in clinical trials, manufactured to ensure quality and consistency, and available on prescription under the care of a doctor. "

EPIDIOLEX is the first pharmaceutical formulation of highly purified cannabidiol (CBD) derived from plants, a cannabinoid without marijuana, and the first in a new class of antiepileptic drugs (AEDs). waiting for a rescheduling that should take place within 90 days.

LGS and Dravet syndrome, which develop in childhood, are serious and rare forms of epilepsy that are notoriously resistant to treatment Most patients with LGS and Dravet syndrome require several antiepileptic drugs and the majority of them are resistant to the currently approved antiepileptic drugs.The daily impact of these conditions is Significant with high rates of early mortality.

"LGS and Dravet syndrome are two of the most severe and difficult forms to treat. infant epilepsy, "said Elizabeth Thiele, MD, director of the d & # 39 program. Pediatric Epilepsy at Massachusetts General Hospital, professor of neurology at Harvard Medical School and principal investigator of the clinical program EPIDIOLEX. "Based on numerous clinical trials, this drug can help meet the needs of this specific pediatric population and is now the first to be approved by the FDA in Dravet Syndrome."

EPIDIOLEX, the first prescription, cannabinoid drug of plant origin in the United States and the first in a new class of antiepileptic drugs.

"For those living with intractable seizures caused by LGS and Dravet syndrome, EPIDIOLEX represents a real medical advance," said Philip Gattone, President and CEO of Foundation for Epilepsy: " The clinical development of these rare and serious diseases is essential, and the news of today brings hope for these patients and their families that a new treatment could help better control their seizures. . In practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and who are asking questions about CBD, "said Orrin Devinsky, MD, of NYU Langone. Health & # 39; s Comprehensive Epilepsy Center and a Senior Investigator in the EPIDIOLEX Clinical Program. "I am delighted that my fellow physicians and I now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and that has been approved by the FDA to treat children and adults."

EPIDIOLEX will be marketed in the United States by Greenwich Biosciences, a US subsidiary of GW Pharmaceuticals plc As part of the approval process, EPIDIOLEX must be reprogrammed from its current Schedule I before it can be made available Patients.A rescheduling is planned within 90 days

GW (NASDAQ: GWPH) GWPH is a biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapeutics. of its patented cannabinoid platform in a wide range of diseases. Cannabinoid derivative derivative, Sativex, which is approved for treatment in many countries outside the United States.

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