The National Institute for Health and Care Excellence (NICE) today issued its final guidance recommending that Aubagio® (teriflunomide 14 mg) should be reimbursed within the National Health Service (NHS) for the treatment of adults with active relapsing remitting multiple sclerosis (RRMS).1 Aubagio is the first oral, once-daily, first-line therapy to significantly reduce annualised relapse rates (primary end point) and the risk of disability accumulation (secondary end point) compared to placebo in Phase III controlled trials2,3 and will provide an alternative to injectable first-line treatment options.
The guidance by NICE represents an important step in improving the standard of care available to people with MS. "MS is a seriously debilitating disease. Teriflunomide is a simple, effective, once-daily oral medication that will be invaluable for people with MS," said Dr. Benjamin Turner, Consultant Neurologist at Barts Health NHS Trust. "This approval is great news for UK patients and especially those who cannot tolerate injections, as until now there have been limited treatment options open to them."
Teriflunomide is a selective immunomodulatory disease-modifying therapy with anti-inflammatory properties administered as a once-daily, oral tablet.4 The European Marketing Authorisation (EMA) of teriflunomide was based on efficacy data from two Phase III clinical trials: TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis).2,3
- In the TEMSO trial, a two-year, randomised, double-blind, multicentre, placebo-controlled Phase III study, teriflunomide 14 mg significantly reduced the annualised relapse rate (primary end point) by 32% (p<0.001) and the risk of sustained disability accumulation (secondary end point) by 30% (p=0.03) versus placebo in patients with RRMS.2
- In the TOWER trial, a randomised, double-blind, multicentre, parallel-group study, teriflunomide 14 mg significantly reduced the annualised relapse rate (primary end point) by 36% (p=0.0001) and the risk of sustained disability accumulation (secondary end point) by 32% (p=0.0442) versus placebo in patients with RRMS.3
- Similar percentage of adverse events, and adverse events leading to treatment discontinuation, were observed with teriflunomide compared to placebo in TEMSO.2 The tolerability and safety experience of teriflunomide based on a robust clinical development programme in MS, showed teriflunomide to be generally well tolerated for a median of 7.1 years.5 In TOWER there was a similar percentage of patients with adverse events in the teriflunomide 14 mg and placebo groups, but a higher percentage of patients receiving teriflunomide 14 mg discontinued treatment compared to the placebo.3
Teriflunomide is the first medicine in Genzyme's pipeline of MS therapies to receive final NICE guidance and become available to patients in the UK. "This is a very exciting time and the launch of Aubagio represents an important milestone for Genzyme as we provide new options to the MS community. Our commitment to improving the lives of people with MS goes beyond advancing treatment options, and we have a patient support programme underway to further support patients with adherence. ," said Brendan Martin, General Manager for Genzyme UK and Ireland.
Approximately 100,000 people in the UK have MS and about 2,500 people are newly diagnosed with it each year.6 Eighty-five percent of people with MS are initially diagnosed with RRMS,7 and people with RRMS experience approximately one or two relapses per year.8 Around half of all relapses may leave people with lingering problems, and symptoms may worsen over time.8,9
About Aubagio® (teriflunomide)
Aubagio is an immunomodulator with anti-inflammatory properties. The exact mechanism by which teriflunomide exerts its therapeutic effect in MS is not fully understood, but this is mediated by a reduced number of lymphocytes.4 Aubagio is supported by an extensive multicentre, multi-country clinical programme, with more than 2,700 trial participants.10 Some patients in extension trials have been treated for up to 8.5 years.5
EU Indication and Usage
Aubagio® (teriflunomide 14 mg) is a once-daily, oral therapy indicated in the European Union for the treatment of adult patients with relapsing remitting multiple sclerosis.4
Genzyme has introduced a risk management plan to ensure that Aubagio® (teriflunomide 14 mg) is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics (SPC) and the Patient Information Leaflet for Aubagio, including the appropriate precautions to be followed, as described in Educational Materials to be used by healthcare professionals and patients..10
For full prescribing information about Aubagio®, the Summary of Product Characteristics can be found here.