UK based biotech firm, GW Pharmaceuticals has recently received a green signal from the U.S. Food and Drug Administration (FDA) for its Epidiolex drug. Reportedly, this cannabis based medicine is formulated to treat epilepsy in children and is claimed to be the first of its kind to get merchandized in the U.S. pharmaceutical market.
For the record, the approval came almost after two years of medical trials that the company conducted. This two-phase trial has proved to be highly effective in treating children detected with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) – two severe and rare forms of epilepsy, for the patients aged 2 years and above.
Reportedly the drug, Epidiolex is derived from CBD (cannabidiol), one of the many molecules found in the marijuana plant. CBD, as per sources, comprises less than 0.1% tetrahydrocannabinol (THC) that is responsible for intoxicating subjects.
Analysts claim that the drug launched by the pharmaceutical company may garner over USD 1 billion in annual sales, becoming GW’s debut ‘blockbuster medication’. Speaking of the development, the chief executive of GW Pharmaceuticals emphasized on a pointer that Epidiolex is a prescription medicine that has shown promising results in reducing seizures during clinical trials.
This drug is also likely to be available made in the UK and Europe market from mid of 2019, though overtly subject to regulatory approval from European Medicines Agency in early next year. It is also expected that the drug would be included into the National Health Service (NHS).
If experts are to be believed, Epidiolex is key breakthrough by GW Pharmaceuticals – one that is likely to aid hundreds of children suffering from epilepsy. In fact, more than 50 children in UK have been already treated with Epidiolex without any cost out of 1500 worldwide, on a compassionate access program.