Biogen gets NICE backing for Vumerity, an oral treatment of RRMS

13 April 2022

UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended Vumerity (diroximel fumarate), a next-generation, oral fumarate, from US biotech Biogen (Nasdaq: BIIB) for the treatment of adults living with active relapsing-remitting multiple sclerosis (RRMS) in England, Wales, and Northern Ireland.

The new oral treatment can reduce the severity and frequency of burdensome gastrointestinal (GI) events like nausea, vomiting, diarrhoea and upper and lower abdominal pain.
Diroximel fumarate demonstrated established efficacy, well-characterized safety, and low discontinuation rates due to an improved GI tolerability profile when compared to established treatment dimethyl fumarate because of bioequivalence.
The medicine was fast tracked to Final Appraisal Determination (FAD) which should enable all eligible patients to have access to diroximel fumarate as soon as possible, providing another important option when considering the right treatment for their individual needs.

Although Vumerity is a follow on for Biogen’s blockbuster drug Tecfidera (dimethyl fumarate) that is already losing patent exclusivity, given the limited advantages of the drug over Tecfidera, as well as the heavy competition among the oral MS therapies, it will likely be difficult for the drug to replicate the impressive growth trajectory of Tecfidera, which had peak global sales of $4.4 billion in 2019, according to a previous report from GlobalData. Tecfidera sales for full-year 2021 were $1.95 billion, while Vumerity revenues hit $410 million.

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