SMC approves diroximel fumarate as multiple sclerosis treatment

pharmafile | February 8, 2022 | News story | Manufacturing and Production  

The SMC has approved VUMERITY (diroximel fumarate), a next-generation oral fumarate for the treatment of adults living with relapsing-remitting multiple sclerosis (RRMS). There are currently 15,000 people living with MS in Scotland.  

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. The SMC announcement means that individuals will have access to a new oral treatment that can reduce the severity and frequency of burdensome GI events like nausea, vomiting, diarrhoea, and upper and lower abdominal pain.

The SMC’s decision was based on data from pivotal Phase III trials which compared diroximel fumarate and dimethyl fumarate, and demonstrated similar efficacy safety profiles.

“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.”

“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.”

Lina Adams

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