A historical day

This is indeed a historical day as no any drug in this category has ever been approved before. I’m talking about the marijuana-based medications. On Jun 25, the FDA gave a thumbs-up to Epidiolex developed by GW Pharma (GWPH) for treating seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older. This approval was highly expected as in April, an FDA advisory panel unanimously voted in favour of recommending approval of Epidiolex. But the surprising piece for the approval is that the indication for the drug is actually broader than expected. In other words, the company use market the drug to a broader patient population with this terrible disease without effective treatment and more patients can benefit from it, a win-win for both the patients and the company!

The historical moment for GWPH actually has a much more impactful implication for the whole marijuana story currently unfolding not only in the US but across the globe. It is still very controversial about the legality of marijuana use and I’m not an expert to tell you which side you should be. But at least I do feel the medical use of marijuana is very convincing and sufficiently based on scientific evidence. The approval of Epidiolex is a living proof of it! If you are not aware of yet, marijuana has two basic components that determines how it behavior in the human body. It contains tetrahydrocannabinol (THC) which is the is the primary psychoactive component of marijuana to cause intoxication or euphoria and therefore makes it addictive. On the other hand, marijuana also has the active molecular entity called cannabidiol (CBD), which does not cause the THC-related problems but rather is medically beneficial to people. This CBD is what Epidiolex is based on and therefore it is does not show the addiction and dependence notoriously related to marijuana as a whole. That’s why FDA Commissioner Scott Gottlieb went further by saying "we'll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products."

 GWPH is the leading biotech in this area and has a great future with a rich portfolio in developing more marijuana-based medicines. Epidiolex will easily be its first blockbuster drug with $1 billion sales in the near future.