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EMA considers new therapies for relapsing remitting MS

15 August 2012

Four new disease modifying drug therapies for relapsing remitting MS - alemtuzumab, teriflunomide, BG-12 (dimethyl fumarate) and laquinimod - have been submitted to the European Medicines Agency (EMA) for licensing.

The EMA examines the effectiveness and safety of new treatments, determines who will most benefit from them, and must be satisfied that they meet manufacturing quality standards before it will issue a licence. Decisions are expected in 2013.

Following licensing these therapies will be assessed by NICE (National Institute for Health and Clinical Excellence). The clinical and cost effectiveness of the treatments will be examined and NICE will decide if the drugs will be made available on the NHS. NICE is currently developing the scope, determining which areas they will examine in detail, of the appraisal.

  • Alemtuzumab is a given as an intravenous (iv) infusion for 3-5 days once a year. In phase III studies, alemtuzumab reduced relapses by approximately 50% more than beta interferon 1a (Rebif). Some studies have found that disability progression has been halted, and in some cases reversed. One in five people experienced significant side effects including abnormal thyroid function. Alemtuzumab was licensed in the UK for use in B-cell chronic lymphocytic leukaemia, a type of cancer, and in organ transplantation. This licence has now been surrendered (there are no safety issues associated with this) in advance of the potential new licence for MS, although people currently receiving this medication should continue to do so.
  • Teriflunomide is given orally as tablets. Results from phase III studies indicate that teriflunomide has similar effectiveness to current disease modifying treatments and no severe side effects have been reported so far.
  • BG-12 (dimethyl fumarate) is also given as a tablet, twice a day. In phase III studies, BG-12 reduced annual relapse rates by about 50% compared to placebo and few serious side effects have occurred in clinical trials.
  • Laquinimod is an oral drug taken once a day that has shown in phase III trials an annual relapse rate 23% lower compared to placebo and a larger proportion of people with no relapses (63% on treatment, 52% on placebo).
Alemtuzumab - Drugs in development
BG-12 - Drugs in development
Teriflunomide - Drugs in development
Laquinimod - Drugs in development
NICE - A-Z of MS
NICE website - proposed technology appraisal