European Medicines Agency recommends licence for cladribine (Mavenclad)


The European Medicines Agency has approved cladribine (brand name Mavenclad) for use with multiple sclerosis.

The agency has recommended that a licence should be granted, by the European Commission, for the treatment of highly-active relapsing MS. Cladribine is currently an anti-cancer drug under the brand names Leustat and Litak.

The next step in the process is for the European Commission to grant a licence.

As far as the UK is concerned, Cladribine will also have to be appraised by National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). These organisations decide whether the drug will be available through the National Health Service.

NICE has already started the appraisal process in anticipation of a European licence being granted. NICE could publish its decision in February 2018. If NICE approves the use of cladribine, it could be available on the NHS as early as June next year.

The medication’s development has met mixed fortunes. Russia and Australia both approved it as an MS treatment in 2010 but Europe and the United States turned it down because of safety concerns.

In 2011, a licence application was refused because of concerns about a higher risk of cancer in people taking cladribine. However, in July last year, Merck announced that further research had found that there is no such increased risk and that the EMA had accepted a new licence application.

How to take cladribine

Patients take cladribine as a pill in two treatment courses:

  • In the first course, a patient takes cladribine pills for five consecutive days in the first month and for five consecutive days in the second month
  • The second course is taken 12 months later. Again a patient takes cladribine pills for five consecutive days in the first month and for five consecutive days in the second month

Cladribine was found to reduce the risk of relapses by 58%, compared to placebo, in large clinical trials. Also, it reduces the risk of increased disability.

Clinical trials reported main side effects include reduced white blood cell counts, which in most cases was mild or moderate, and infections including herpes zoster (shingles).

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at with other companies and products. Read more.

* * * * * is the personal website of Ian Franks, a Features Writer with Medical News Today. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.


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