GW Pharmaceuticals’ Epidiolex Wins New FDA Approvals

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The company’s star CBD drug can now be prescribed for a brand-new condition, and its age range for a previous approval has been broadened.

Eric Volkman

GW Pharmaceuticals( NASDAQ: GWPH) cannabidiol (CBD) drug Epidiolex has actually been given Fda approval for a new indicator. In addition, its previous approval has been broadened to cover a broader age series of patients.

The business revealed Monday early morning that the FDA had authorized the oral option of Epidiolex as a treatment for seizures in patients age 1 and older suffering from tuberous sclerosis complex (TSC)– an unusual genetic disorder in which benign tumors can grow throughout the body; the disease can likewise cause epilepsy.

The FDA also expanded its approval of Epidiolex to treat seizures in patients affected with Lennox-Gastaut syndrome or Dravet syndrome, two rare forms of epilepsy. Just like TSC, the drug can now be administered to patients with these conditions who are age 1 and older.

A medical professional working with cannabis extract.

Image source: Getty Images.

In 2018, Epidiolex (marketed as Epidyolex in Europe) became the first and so far only cannabidiol– obtained medication to be approved approval by the FDA. GW Pharmaceuticals is a U.K.-based specialty pharmaceutical business that concentrates on establishing and marketing treatments based upon CBD.

” This label growth, consisting of the growth of the age variety in all authorized indicators, further demonstrates that the FDA process can continue to make it possible for wider patient access to properly evaluated regulative authorized cannabinoid medications,” said CEO Justin Gover.

” It likewise provides expect these clients and their families and is yet another essential milestone for Epidiolex as a first-in-class antiepileptic drug,” he added.

Investors appear to agree. In late-afternoon trading on Monday, GW Pharmaceuticals’ shares were up by about 4.5%, well exceeding the gains of the wider stock market.


Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.”> Eric Volkman has no position in

any of the stocks pointed out. The Motley Fool has no position in any of the stocks mentioned.
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