The UK’s Medicines and Healthcare products Regulatory Agency just issued a “positive opinion” for CBD medicine. The agency also released its guidance on CBD labeling, which will go into effect in 2021.
The “CBD Medicine Given TSC Green Light In The UK” is a story about CBD and how it has been given the green light in the United Kingdom. This article will discuss what hemp and CBD are, as well as their similarities and differences. Read more in detail here: is hemp and cbd the same.
GW Pharmaceuticals, a Jazz Pharmaceuticals company, has obtained clearance in the United Kingdom for the use of Epidyolex to treat seizures caused by tuberous sclerosis complex (TSC).
Tuberous sclerosis complex is a rare genetic disorder that causes benign tumors in the brain and other critical organs to develop. Seizures and delayed intellectual development are two of the numerous consequences of the disease when it is severe. Conventional treatments for seizures are often ineffective.
TSC is a condition that is usually diagnosed in childhood and affects between 3,700 and 11,000 individuals in the United Kingdom.
Epidyolex (known as Epidiolex in the United States) is already being used in the United Kingdom to treat seizures caused by Lennox Gastaut syndrome (LGS) and Dravet syndrome. The Therapeutic Goods Administration (TGA) in Australia authorized it for the same purposes in September of last year.
TSC has recently been authorized by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) as an additional treatment for children aged two and above who are taking clobazam (a benzodiazepine class drug).
Jazz Pharmaceuticals’ Chris Tovey stated, “The UK is an important nation for us for many reasons, and we are pleased to be able to provide a medication that was developed and produced here to even more patients throughout the UK.”
All 27 European Union nations, as well as Norway, Iceland, Liechtenstein, and Northern Ireland, have given their support.
In a Phase 3 safety and efficacy trial examining cannabidiol, patients receiving 25 mg/kg/day had a 49 percent decrease in seizures compared to 27 percent for placebo.
Epidyolex is a very costly drug, but GW is working with key UK partners, notably the National Institute for Health and Care Excellence (NICE), to obtain payment for qualified patients.
Epidiolex was the first CBD medication to get FDA approval in the United States for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
Jazz Pharmaceuticals was acquired by Jazz in May for a total value of roughly USD $7.2 billion, or $6.8 billion net of GW cash.
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