Australia’s TGA Approves Cannabidiol (CBD) Medicine

GW Pharmaceuticals - Epidyolex in Australia

GW Pharmaceuticals announced last week the Australian Therapeutic Goods Administration (TGA) has approved its cannabidiol medicine Epidyolex for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older.

LGS and Dravet syndrome are both rare and severe forms of epilepsy, and are resistant to treatment through the use of conventional medications. Those who suffer from either condition can experience multiple seizures each day.

Epidyolex, which is marketed as Epidiolex in the USA, has been a winner for GW Pharmaceuticals.

Epidiolex was the first CBD medicine approved by the USA’s Food and Drug Administration (FDA). It then went on to get approval in the European Union for the treatment of Lennox‑Gastaut syndrome and Dravet syndrome.

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In April this year the United States Drug Enforcement Administration (DEA) determined Epidiolex was no longer subject to the Controlled Substances Act (CSA), and immediately descheduled the medication. Then in June, the UK Home Office rescheduled Epidyolex from a Schedule 5 to Schedule 2 drug; making it easier to access and cheaper over there – the latter important as it is crazy expensive stuff.

In August, Epidiolex was approved by the US FDA for the treatment of seizures associated with tuberous sclerosis complex (TSC) – achieving a goal GW Pharmaceuticals had set itself for the year.

GW has partnered with Chiesi Australia to make Epidyolex available in Australia. Chiesi Australia only came into being this year – the result of Melbourne’s Emerge Health being acquired by Chiesi Farmaceutici, an Italian global pharmaceutical company.

“We are delighted to announce the TGA registration of EPIDYOLEX®, an important step forward for the management of LGS and Dravet syndrome,” said Chris Rossidis, General Manager, Chiesi Australia. “We are working closely with the Department of Health to achieve greater access to this medicine as soon as possible.”

As for the cost side of things, which would certainly limit accessibility to patients and their families, the two companies will work with Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) to secure reimbursement via the Pharmaceutical Benefits Scheme (PBS).