The MHRA has granted marketing authorisation for diroximel fumarate as oral treatment for relapsing-remitting multiple sclerosis.
Vumerity (diroximel fumarate) is a next-generation oral fumarate treatment for adults with relapsing-remitting multiple sclerosis (RRMS). It is an oral fumarate with an improved chemical structure to dimethyl fumarate, and once in the body, it rapidly converts to monomethyl fumarate. It has established efficacy and well-characterised safety, building on Biogen’s leadership in MS oral therapies.
In the UK, approximately 130,000 people are living with MS and nearly 7,000 are newly diagnosed each year, heightening the increasing need for new treatment options.
The MHRA and European Commission (EC) approval of this treatment is based on data from pharmacokinetic bridging studies comparing diroximel fumarate and dimethyl fumarate.
Dr Mihaela Vlaicu, head of Medical Affairs, Biogen UK and Ireland: “Everyone’s experience of MS is unique, it can be unpredictable and emotionally and physically challenging. It is important that people have MS treatment options available to them that can be easily integrated into their daily life. This new option provides flexibility for people living with MS, to be treated without having to think about dietary restrictions or when to take a dose in relation to mealtimes.”
Jonathan Randell, senior director, Value & Access, Biogen UK and Ireland, added: “The approval of diroximel fumarate by the MHRA, and subsequently by the EC, highlights the importance of treatment adherence, which can make a meaningful difference on treatment outcomes when living with a chronic disease.
“It provides a new oral treatment option for patients with low gastrointestinal discontinuation rates, that may help patients to start and adhere to treatment. This is another milestone in our ambition as a company to advance treatment and improve outcomes for people living with MS and we are working towards ensuring access across the UK&I.”
