SMC Says Yes to Aubagio® (teriflunomide), a New Once Daily First-line Oral Treatment Available for People with an Active Relapsing Remitting Form of MS

OXFORD, England, March 10, 2014 /PRNewswire/ --

New oral treatment can be offered as an alternative to currently available injectable treatment options

"The prevalence of multiple sclerosis in Scotland is one of the highest in the world, so the approval of Aubagio as another treatment option will be welcomed by the Scottish MS community. Aubagio is an oral drug, taken once daily and this makes it an exciting development both for people with MS and their clinicians, providing more choice and an alternative to injections. This is a really positive development for the future of treatment for relapsing remitting MS," commented Amy Bowen, Director of Service Development at the MS Trust.

The Scottish Medicines Consortium (SMC) today published its advice that Aubagio^® (teriflunomide) 14 mg tablets has been accepted for use by NHS Scotland for the treatment of adults with relapsing remitting multiple sclerosis (RRMS), as an alternative to the currently available treatment options beta interferon or glatiramer acetate.^[1]   The guidance does not include patients with highly active MS.  

The guidance published by the SMC today represents an important step in improving the standard of care available to people with MS. "MS is a real concern in Scotland as it is a debilitating disease which has a high prevalence.  This is good news for people with MS in Scotland and a significant milestone in improving the care of MS patients here," said Dr. Belinda Weller, Consultant Neurologist, Western General Hospital, Edinburgh.

Scotland has among the highest prevalence of MS in the world, with around 10,000 people living with MS in the country^[2]. Eighty-five percent of people with MS are initially diagnosed with RRMS and people with this type of MS experience approximately one or two relapses per year.^[3] Around half of all relapses may leave people with lingering problems and disability may accumulate over time.^[3],[4]

Aubagio is the first medicine in Genzyme's pipeline of MS therapies to receive final SMC guidance and become available to patients in Scotland. "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.

Online media resources available here: www.mspressoffice.co.uk.

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.^[5] Aubagio is supported by an extensive multicentre, multi-country clinical programme, with more than 2,700 trial participants.^[6] Some patients in extension trials have been treated for up to 8.5 years.^[7]

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.^[5]

Genzyme has introduced a risk management plan to ensure that 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.^[6]

For full prescribing information about Aubagio, the Summary of Product Characteristics can be found here http://www.medicines.org.uk/emc/medicine/28533/SPC/AUBAGIO+14+mg+film-coated+tablets/

About Genzyme, a Sanofi Company

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

About Genzyme in the UK

Genzyme is a significant force in the UK biotechnology sector focused on improving the lives of patients with rare genetic diseases and multiple sclerosis. First established in the UK in 1981, Genzyme employs 450 people at two sites. Genzyme Therapeutics in Oxford is the company's UK commercial base marketing products for the treatment of patients with chronic debilitating diseases. These include genetic diseases such as lysosomal storage disorders (LSDs) - characterised by a lack of enzymes essential to healthy biological processes - and multiple sclerosis - a complex neurological disease affecting the central nervous system. Our portfolio also includes a therapy which aids in the management of thyroid cancer.

Genzyme's manufacturing facility in Haverhill, Suffolk, now integrated with Sanofi's Pharma  Operations Unit, has undergone a dramatic building programme since its purchase in 1982 and now employs 380 people at a site with two large-scale manufacturing plants, a pilot plant, a development centre, warehouse and other associated facilities. The Haverhill facility manufactures the active ingredients in therapies for patients undergoing renal dialysis and is a major global distribution centre for Genzyme's products for genetic diseases. Learn more at http://www.genzyme.co.uk

Genzyme^® is a registered trademark.  All rights reserved

References

1. SMC guidance. teriflunomide, 14mg, film-coated tablets (Aubagio®)  http://www.scottishmedicines.org.uk

2. Scottish Public Health Authority. Multiple sclerosis: key points. Available online at www.scotpho.org.uk/health-wellbeing-and-disease/multiple-sclerosis/key-points [Accessed December 2013]

3. MS Society UK. Relapsing-Remitting MS (RRMS). http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms    [Accessed January 2014]

4. Multiple Sclerosis Trust. Types of MS. http://www.mstrust.org.uk/atoz/types.jsp [Accessed October 2013]

5. Aubagio Summary of Product Characteristics November 2013

6. 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]

7. 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