The European Commission (EC) has granted marketing authorization for cladribine (Mavenclad) for the treatment of adults with highly active relapsing multiple sclerosis. This follows a recommendation from the European Medicines Agency in June that a licence should be granted.
Cladribine will now need to be appraised by NICE and the SMC to determine NHS availability in the UK. NICE has started the process and the MS Trust is contributing to the appraisal. A decision from NICE is expected to be published in February 2018, with the drug potentially available on the NHS in England and Wales three months later.
Cladribine is taken as a pill in two treatment courses, twelve months apart:
- in the first course you take 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; you take cladribine pills for five consecutive days in the first month and for five consecutive days in the second month
In large clinical trials, cladribine reduced the risk of relapses by 58% compared to placebo. Cladribine also significantly reduced the risk of increased disability which persisted for 3 or 6 months.
The main side effects reported in clinical trials include reduced white blood cell counts which in most cases were mild or moderate but were considered more severe in about 25% of those taking cladribine, and infections, including herpes zoster (shingles).