New daily tablet licensed for people with relapsing remitting MS

Published date: 02 Sep 2013 at 1:21PM

The manufacturer of Aubagio (also known as teriflunomide), has received marketing authorisation in Europe for a 14mg once a day oral treatment for people with relapsing remitting MS.

Aubagio was shown to be safe and effective in two phase 3 (late-stage) clinical trials in people with relapsing remitting MS. The trials showed that 14mg once-daily tablets resulted in around a 30 per cent reduction in annual relapse rate.

14mg of Aubagio also reduced lesion volume - as measured by an MRI brain scan - by 67-80 per cent, and reduced sustained disability progression over a 12 week period by around 30 per cent.

What happens now?

This means that Aubagio now has a licence in Europe. We now await Sanofi (the manufacturer) to launch the drug in the UK, so that it can be available for neurologists to prescribe.

Before the drug can be prescribed on the NHS, the National Institute for Health and Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC) will need to undertake appraisals to judge its cost-effectiveness.

How does Aubagio work?

Aubagio affects the immune system by blocking the action of a specific set of immune cells called T-cells, which are thought to be responsible for causing damage to the brain and spinal cord in people with MS. Other cells of the immune system are thought to be left intact, affording people with MS some immune protection against infections.

Nick Rijke, interim Director of Policy and Research at the MS Society said:

“We are delighted that another oral tablet has been licensed for people with relapsing remitting MS. Once the drug has been launched in the UK, we will do everything we can to support people with MS to get access to it.”

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Page last updated: 02 Sep 2013

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