Tecfidera gets European licence

04 February 2014

Author: MS Trust

The EMA, the European drug regulator, has granted a licence to dimethyl fumarate (Tecfidera / BG-12) as a first line treatment for relapsing remitting MS.

Dimethyl fumarate is taken orally as tablets, two times per day. In the two pivotal studies of the drug it was shown to reduce the number of relapses by half when compared to placebo. The risk of an increase in disability, as measured by the EDSS scale, lasting at least 12-weeks was reduced by a third in one trial.

The most common side effects seen in the trials were flushing and feeling hot, gastrointestinal upset (diarrhoea, nausea, abdominal pain) and headache.

Dimethyl fumarate will need to be appraised by NICE and the SMC to determine availability in the UK.

The news comes two weeks after teriflunomide (Aubagio), another drug for relapsing remitting MS, was approved by NICE for use in the NHS in England and Wales. The SMC's decision on whether to approve teriflunomide in Scotland is expected this week.

Amy Bowen, the MS Trust's Director of Service Development, said,

This is good news. The MS Trust is participating in the NICE and SMC consultations to get Tecfidera available on the NHS. Together with the recent approval of teriflunomide the range of treatments is expanding for people with relapsing remitting MS. With more available, it is becoming increasingly important for people to talk through all their options with their neurologist and MS specialist nurse and to understand the benefits and risks of each of the drugs."