Creating a free account will enable you to subscribe to our daily and weekly email newsletters, as well as customize your reading experience to show only the categories most relevant to you.
Signing up only take a few minutes, so why not give it a try and see what you've been missing out on.
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
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.
1. National Institute for Health and Care Excellence. Final appraisal determination (FAD). Teriflunomide for treating relapsing–remitting multiple sclerosis. November 2013
2. O’Connor P et al. Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis. N Engl J Med 2011;365:1293-303
3. Miller AE et al. Teriflunomide Efficacy and Safety in Patients with Relapsing Multiple Sclerosis: results From TOWER, a Second Pivotal Phase 3 Placebo-Controlled Study. Presented at the American Academy of Neurology (AAN) annual meeting, San Diego, 2013; S01.004
4. Aubagio Summary of Product Characteristics November 2013
5. Confavreux C et al. Teriflunomide Multiple Sclerosis Trial Group. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler J 2012 Sep;18(9):1278-1289
6. NICE Proposed Health Technology Appraisal. Alemtuzumab, dimethyl fumarate, laquinimod and teriflunomide for the treatment of relapsing forms of multiple sclerosis. Draft scope. http://www.nice.org.uk/nicemedia/live/14061/63485/63485.pdf [Accessed October 2013]
7. MS Society. Relapsing Remitting (RRMS). http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms [Accessed January 2014]
8. Multiple Sclerosis Trust. Types of MS. http://www.mstrust.org.uk/atoz/types.jsp [Accessed October 2013]
9. MS Society UK. Relapsing remitting MS. http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms [Accessed November 2013]
10. EPAR Summary for the public . Aubagio (teriflunomide). European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002514/WC500148685.pdf. [Accessed December 2013]
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our Multiple Sclerosis category page for the latest news on this subject.
Please use one of the following formats to cite this article in your essay, paper or report:
Genzyme. "NICE recommends once-daily oral medicine Aubagio® for the treatment of active relapsing remitting multiple sclerosis." Medical News Today. MediLexicon, Intl., 22 Jan. 2014. Web.
18 Apr. 2014. <http://www.medicalnewstoday.com/releases/271496>
Genzyme. (2014, January 22). "NICE recommends once-daily oral medicine Aubagio® for the treatment of active relapsing remitting multiple sclerosis." Medical News Today. Retrieved from
Please note: If no author information is provided, the source is cited instead.
For any corrections of factual information, or to contact our editorial team, please use our feedback form. Please send any medical news or health news press releases to:
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.
This page was printed from: http://www.medicalnewstoday.com/releases/271496.php
Visit www.medicalnewstoday.com for medical news and health news headlines posted throughout the day, every day.
© 2004-2014 All rights reserved. MNT is the registered trade mark of MediLexicon International Limited.