GW Pharmaceuticals (GWPH.Q) has received a recommendation from the European Medicines Agency (EMA) for the authorization of the company’s Epidyolex cannabis oral solution for use in the treatment of seizures.
The recommendation came from EMA’s committee for medicinal products for human use, and covers the drugs use for seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.
“Today’s positive CHMP opinion for EPIDYOLEX™ marks a major milestone for patients, and their families, battling to control two of the most severe and life-threatening forms of childhood onset epilepsy. Cannabidiol oral solution is the first in a new class of epilepsy medicines and the first plant-derived cannabis-based medicine to be submitted for European regulatory review, representing a historic breakthrough,” said Justin Gover, GW’s CEO
Martin Brodie, president of the International Bureau for Epilepsy, said the recommendation ” brings hope to both patients and their families” in the search for treatments.
The U.S. FDA approved GW Pharma’s oral solution in June 2018 under the trade name Epidiolex for use in treating certain types of seizures in patients 2 years of age or older.
The European Commission (EC) is expected to give their decision on wether or not to approve the drug’s marketing authorization applications (MAA) within two months.
“Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein,” according to the EMA website.
What GW’s recommendation means
In BioPharmaDive, Jacob Bell wrote sales of Epidiolex have already surpassed Wall Street’s expectations.
Sales “totaled $33.5 million in the first quarter, which was more than double what analysts had predicted,” according to Bell.
And with their most recent recommendation, Epidiolex is poised to expand into the European markets.
B.C. (before cannabidiol)
The drug was designed to treat both Dravet syndrome and Lennox-Gastaut syndrome (LGS), two rare types of epilepsies. LGS affects only 2 to 5% of childhood epileptics while it is believed 3 to 8% of children who have their first seizure within their first year of life may have Dravet syndrome.
Before Epidiolex’s approval, treatment for epilepsy, and both Dravet Syndrome and LGS, has been an inexact science.
According to epilepsy.com, “Treatment [for LGS] is difficult, because the seizures often don’t respond to seizure medications, also know as anti-epileptic drugs (AEDs). The intellectual changes do not respond to any currently available medicine or treatment either.”
Whereas Dravet syndrome can require two or more medications, and certain medications—sodium channel blockers—can even worsen conditions.
It’s clear there’s a market for these drugs, and with some evidence to indicate epilepsy rates are increasing in the U.S., the timing couldn’t be better.