Infarmed generates confusion over approval of Epidiolex in Europe

The President of Infarmed, Maria do Céu Machado, said today, at a conference on medical cannabis, that Epidiolex, a CBD (cannabidiol)-based drug from GW Pharmaceuticals, will not have been approved by the European Medicines Agency (EMA).

The EMA has already made it known, however, that “the evaluation of the application is still ongoing”, and GW Pharmaceuticals, the maker of Epidiolex, warns that this information is “incorrect” and that it awaits an opinion from the EMA in “mid-2019”. ”.

In view of these reactions, Infarmed reviewed the statements and clarified that it was referring only to one of the discussions on the drug at the CHMP — EMA Committee for Medicinal Products for Human Use.

Statements generate misunderstanding

Maria do Céu Machado was giving the closing speech of a conference promoted by Abreu Advogados in partnership with Wise HS, dedicated to “market perspectives on the medical cannabis industry”, stating that Infarmed had access to a communication from the EMA (European Medicines Agency) “about one or two weeks ago”, in which it was mentioned that “the benefits of CBD alone were not clear” and that “clinical trials failed to provide robust scientific evidence” that justify its approval in Europe. At the end of the conference it was not possible to ask further questions or obtain details on this issue.

Contacted by CannaReporter, the EMA clarified that “the assessment of the marketing authorization application for cannabidiol, an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), is still in progress“, referring to Epidiolex (“cannabidiol”) on the list of drugs under evaluation.

For your side, GW Pharma told CannaReporter that the information provided by Infarmed “is incorrect” and that “the oral cannabidiol solution (known as Epidiolex in the US) is still under regulatory review by the EMA”. GW added that “the regulatory review of the oral cannabidiol solution is entering its final stages and we expect the EMA’s Committee for Medicinal Products for Human Use (CHMP) to issue an opinion in mid-2019.”

The EMA added that “when the Committee for Medicinal Products for Human Use (CHMP) reaches a conclusion, its recommendation will be published in the CHMP meeting highlights (they are published on the Friday after each meeting at noon). The CHMP meets once a month and topics discussed in a given month are included in the agenda, published at the beginning of each meeting”.

Contacted again, Infarmed clarified, after all, that “the drug is still under evaluation” and that Maria do Céu Machado was referring only to one of the EMA reports: “Epidiolex was not approved in one of the CHMP discussions, but that does not mean that cannot continue to be discussed”, Hugo Grilo, Infarmed's press advisor, said over the phone. Hugo Grilo added that there were “major objections” to one of the evaluations and discussions on Epidiolex at the CHMP, but did not provide further details.

CannaReporter looked for this information on the EMA website, without success, so they contacted the EMA again.

EMA clarifies that CHMP only pronounces at the end of the evaluation

In an emailed response, the EMA explained the following:

“As this drug is still under evaluation, we cannot provide further information at this stage. The CHMP only adopts a formal opinion on a marketing authorization application at the end of its assessment. During its assessment, the CHMP discusses an application at various plenary meetings, may raise questions about the evidence provided in the application, and ask the applicant to provide further clarification or analysis to resolve these issues.

The evaluation of a new drug application takes up to 210 “active” days. This active assessment time is interrupted by at least one “end point” during which the applicant prepares answers to the CHMP's questions. You can find information on the status of the evaluation in the CHMP agendas and minutes. Drugs approaching the end of the evaluation and for which the CHMP is expected to adopt an opinion are listed in section 3.1.

As explained, more information will be provided in the CHMP highlights once the Committee adopts an opinion. In addition, once a decision has been made on whether to authorize or refuse a marketing authorisation, the EMA also publishes a comprehensive set of documents called the European Public Assessment Report. This includes the CHMP public assessment report, which describes in detail the data assessed and why the CHMP recommended authorization or denial of authorization”.

Dravet Portugal awaits approval of Epidiolex 

Epidiolex is expected with some expectation by the Dravet Portugal Association, which represents children suffering from this rare form of epilepsy. Speaking to CannaReporter, Víctor Mateus, vice-president of Dravet, said that the Association has not received so far any official information containing the EMA’s formal decision on the application for marketing the orphan drug “Epidiolex” in the European space, requested by GW Pharmaceuticals. , therefore, it considers it premature to comment on the alleged negative deliberation of the EMA to the same, announced today in the context of the conference promoted by Abreu Advogados”.

Victor Mateus added that the EMA had already assigned the designation of an orphan drug to “Epidiolex” whose active principle is CBD and that in Portugal there are “some patients with Dravet Syndrome who complement their epilepsy therapy with oil-based formulations”. of CBD, as in other countries in the world, which show clinical improvements”.

Epidiolex — Cannabidiol alone costs 28 euros/year in the US

Epidiolex is manufactured by the English pharmaceutical GW Pharmaceuticals and has only cannabidiol (CBD) in its composition, a non-psychotropic component of the Cannabis sativa L. plant, being a purified form of one of the more than 100 cannabinoids present in the plant. The price of conventional treatment with Epidiolex costs, in the US, about 32.500 dollars per year (28.783 euros).

Remember that the Epidiolex was approved in 2018 in the United States of America (USA) by the FDA (Food and Drug Administration), with indication in seizures associated with refractory epilepsies, namely Dravet and Lennox-Gastaut syndromes, and in patients over two years of age.

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Updated at 20:52.
Featured photo: DR