The Scottish Medicines Consortium (SMC) approves diroximel fumarate as an oral treatment for relapsing-remitting multiple sclerosis (RRMS)

The Scottish Medicines Consortium (SMC) approves diroximel fumarate as an oral treatment for relapsing-remitting multiple sclerosis (RRMS)

• Diroximel fumarate is a new, at-home oral treatment for those living with relapsing-remitting multiple sclerosis (RRMS) in Scotland, with established efficacy and well-characterised safety¹
• Phase 3 data and real-world evidence (n=160 based in the US) have demonstrated that treatment with diroximel fumarate results in low discontinuation rates due to its gastrointestinal (GI) tolerability profile^2-6
• SMC decision strengthens Biogen’s established MS portfolio and commitment to introducing new oral therapies that positively impact the lives of those living with MS

Maidenhead, UK. – FEBRUARY 7, 2022 – Biogen UK today announced that the Scottish Medicines Consortium (SMC) has approved VUMERITY^® (diroximel fumarate), a next-generation oral fumarate, for use in Scotland, for the treatment of adults living with relapsing-remitting multiple sclerosis (RRMS). 15,000 people are currently living with MS in Scotland.⁷ RRMS is the most common form of the condition and diroximel fumarate offers those living with RRMS a treatment option with an improved gastrointestinal (GI) tolerability profile and comparable efficacy and safety characteristics to established treatment dimethyl fumarate (due to bioequivalence).^2-5,8  Today’s announcement provides these individuals with access to a new oral treatment that can reduce the severity and frequency of burdensome GI events like nausea, vomiting, diarrhoea and upper & lower abdominal pain.^1-5 Additionally, the new treatment offers the convenience and flexibility to be taken with or without food.¹

“Disease-modifying therapies can successfully decrease the chances of relapses and improve the quality of life for those living with MS. The challenge can be keeping people on these effective treatments long-term; therefore, new efficacious options with improved tolerability profiles such as diroximel fumarate, are welcomed to help people start and stay on treatment.” said Dr Martin Duddy, Consultant Neurology, Royal Victoria Infirmary, Newcastle. “Diroximel fumarate also provides an alternative option for those people experiencing stomach issues with their current oral DMT, allowing them to live more comfortable lives, while avoiding switching to an injectable therapy.”

The SMC’s decision was based on data from pivotal phase 3 trials (EVOLVE-MS-1 and EVOLVE-MS-2), which compared diroximel fumarate and dimethyl fumarate and demonstrated similar efficacy safety profiles.^4,5 GI events such as nausea, vomiting, diarrhoea and upper & lower abdominal pain were less severe and lasted fewer days with diroximel fumarate compared with dimethyl fumarate and therefore were less likely to interfere with patients’ daily lives.^4,5  In addition, since diroximel fumarate’s launch in the US, real-world evidence has reinforced the GI tolerability profile and confirmed that patient experience demonstrated in clinical trials is consistent with clinical practice. The real-world retrospective analysis of persistence and adherence in DRF-treated patients (n=160) showed high overall persistence (88.65%), low discontinuation rate due to GI AEs (3.8%, 6/160) and high adherence to therapy (mean PDC 91.4%)*, aligning with expectations based on DRF clinical trials. ⁶

“Effective treatments that fit into daily life can help people live a life with MS that is not defined by MS. People living with MS can be confident in the established efficacy of this new oral treatment that has fewer stomach problems to manage. This can mean that they don’t have to factor their medication in relation to mealtimes.” said David Martin, CEO, MS Trust.

“Throughout the last 25 years, we have been dedicated to delivering high-quality treatments that support the realities of living with MS, which will differ from person to person.” said Dr Mihaela Vlaicu, Head of Medical Affairs, Biogen UK and Ireland. “The SMC approval of diroximel fumarate marks our third MS product launched in the last 12 months in Scotland and aids us in delivering on our commitment to introduce new therapies that can individualise treatment options and improve MS care.”

Biogen continue to work closely with the National Institute for Health and Care Excellence (NICE), following the submission of diroximel fumarate via the NICE Fast Track (FTA) approval route. Biogen are committed to supporting access to further treatment choices for those living with MS in England and Wales.