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US approval for first ever cannabis-based medicine

UK company's Epidiolex tipped to be blockbuster

GW Pharma has gained an historic approval for its drug Epidiolex, the first ever prescription medicine derived from cannabis.

Epidiolex is the first medicine based on highly-purified, plant-derived cannabidiol (CBD), which lacks the high associated with marijuana, and is the first in a new category of anti-epileptic drugs (AEDs).

The oral solution is now approved to treat seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older, two of the most difficult-to-treat epilepsy related conditions.

Analysts believe that if GW Pharma can successfully commercialise the drug in the US and other major global markets, and add further indications, it could have a blockbuster treatment on its hands worth $2-3billion a year.

The company will have to wait a little longer before it can launch the product, however, because its active ingredient, CBD, needs to be rescheduled under US law.  Even though it doesn’t produce a high, CBD is still categorised as a Schedule 1 substance, which is for drugs with no therapeutic value and high probability of abuse.

Once this recategorisation is completed within the next 90 days, GW Pharma will launch Epidiolex in the US.

The company has come a long way since two British biotech entrepreneurs, Geoffrey Guy and Brian Whittle, established the company in 1998.

Having battled against misconceptions about the therapeutic mechanism of their cannabinoid medicines, and having persuaded regulators in the UK, US and beyond to accommodate their medicines, the Epidiolex approval is the company’s big breakthrough.

Justin Gover

The company’s first CBD product was Sativex, first approved over a decade ago, but Epidiolex has built up a more compelling evidence base in these hard-to-treat conditions.

“Today’s approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies,” said Justin Gover, GW’s chief executive.

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

Phase 3 studies showed Epidiolex added to other epilepsy therapies significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome. The drug was generally well tolerated, though the most common adverse reactions included somnolence, decreased appetite, diarrhoea; transaminase elevations and fatigue.

GW Pharma has already filed with the FDA for a second indication, in Tuberous Sclerosis Complex, with a decision expected in Q1 2019

In Europe, the EMA is also reviewing the drug for the same two conditions, with a decision expected in the first quarter of 2019.

The company is already gearing up for the drug’s launch in Europe, with commercial teams now in place in five major European markets.

Article by
Andrew McConaghie

26th June 2018

From: Regulatory



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