A new cannabis-based drug for rare forms of childhood epilepsy has been given the green light for the EU market, making it the second medicinal cannabis product to get approval by the EU's drug agency.
The EU's Medicines Agency cleared the market commercialisation of Epidyolex, which, in conjunction with the drug clobazam, can treat two rare but severe forms of childhood epilepsy in patients over two years old, RTBF reports.
The active substance in Epidyolex, which is already sold in the United States, is cannabidiol, described as an anti-epileptic in a statement in the agency's website and known commercially as CBD, which does not provide the high normally associated with cannabis.
Clinical trials in over 700 patients showed that Epidyolex efficiently reduced symptoms of children suffering from Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), which impact around 50,000 people in Europe.
Both syndromes are rare but severe forms of epilepsy affecting children, with LGS' sudden "drop seizures" —which cause patients to fall to the ground— sometimes being so frequent and severe they require surgery.
The frequency of the seizures brought on by both syndromes often leads to cognitive dysfunction and behavioural disorders, with the seizures of Dravet syndrome becoming worse as patients age.
During the clinical trial, the newly approved drug was shown to reduce the frequency and severity of the seizures for both syndromes, with industry reports saying it may help to improve development and behaviour.
The drug's approval marks the second cannabis-based medicinal product approved for the EU market, and the first one which targets epileptic patients, after Sativex, a medicine for multiple sclerosis, received approval in 2016.
Industry officials must now complete price negotiations for Epidyolex's entry into the EU market. In the U.S., one year's worth of treatment for the medicine, an orally-ingested liquid, costs patients around $32,500.
The Brussels Times