NICE backs Biogen's Vumerity for multiple sclerosis

Patients with relapsing-remitting multiple sclerosis (RRMS) in England, Wales and Northern Ireland can now access treatment with Biogen's oral therapy Vumerity, after NICE recommended the drug for routine NHS use.

The decision means that Vumerity (diroximel fumarate) – a follow-up to Biogen's older oral therapy Tecfidera (dimethyl fumarate) – is now available to eligible patients across the UK, as the Scottish Medicines Consortium approved the drug in February.

NICE's final appraisal document for Vumerity has been welcomed by patient organisation the MS Trust, which said that Vumerity is as effective as Tecfidera but has fewer gastrointestinal side effects like nausea, vomiting, diarrhoea and upper & lower abdominal pain. Unlike Tecfidera, it can also be taken either with a meal or on an empty stomach.

A head-to-head trial of Vumerity versus Tecfidera found that the rate of treatment discontinuation with the new drug due to GI side effects was 1%, compared to nearly 5% with its predecessor.

Both drugs are converted to monomethyl fumarate which reduces inflammation caused by MS activity and may protect nerve cells from damage.

"People living with MS can be confident in the established efficacy of this new oral treatment that has fewer stomach problems to manage," said MS Trust chief executive David Martin. "This can mean that they don't have to factor their medication in relation to mealtimes."

It's an important decision for Biogen, as Vumerity is viewed as an important revenue generator for the drugmaker as Tecfidera starts to see its sales decline due to generic competition.

The new drug was approved in Europe towards the end of last year but in the US – where it has been available since 2019 – it is starting to close the gap with a quickly declining Tecfidera.

US sales last year reached $409 million, versus $681 million for its predecessor, although it still has a long way to go to reach Tecfidera's 2019 peak of $3.3 billion from the US market.

Meanwhile, Biogen is facing challenges elsewhere, notably with its stalled Alzheimer's therapy Aduhelm (aducanumab) and spinal muscular atrophy treatment Spinraza (nusinersen), which is seeing sales decline as a result of greater competition in the market.