NICE Approves Biogen's Vumerity for Relapsing-Remitting Multiple Sclerosis with Improved Tolerability Profile

Key Insights

• NICE has recommended Biogen's oral therapy Vumerity (diroximel fumarate) for routine NHS use in patients with relapsing-remitting multiple sclerosis across England, Wales, and Northern Ireland.
• Clinical data shows Vumerity matches Tecfidera's efficacy while demonstrating significantly lower gastrointestinal side effects, with only 1% treatment discontinuation rate compared to 5% for Tecfidera.
• The approval represents a significant milestone for Biogen as Vumerity aims to succeed Tecfidera, which has seen declining sales due to generic competition, with US sales reaching $409 million compared to Tecfidera's $681 million.

The National Institute for Health and Care Excellence (NICE) has expanded treatment options for patients with relapsing-remitting multiple sclerosis (RRMS) by recommending Biogen's Vumerity (diroximel fumarate) for routine NHS use in England, Wales, and Northern Ireland. This approval follows the Scottish Medicines Consortium's earlier endorsement in February, making the treatment available across the entire United Kingdom.

Enhanced Tolerability Profile

The MS Trust has welcomed NICE's final appraisal, highlighting Vumerity's improved gastrointestinal tolerability compared to its predecessor, Tecfidera (dimethyl fumarate). Head-to-head clinical trials demonstrated a significant reduction in treatment discontinuation rates due to gastrointestinal side effects, with Vumerity at 1% compared to Tecfidera's nearly 5%.

David Martin, MS Trust chief executive, emphasized the treatment's benefits: "People living with MS can be confident in the established efficacy of this new oral treatment that has fewer stomach problems to manage." The drug offers additional flexibility as it can be taken with or without food, unlike Tecfidera.

Mechanism of Action and Clinical Impact

Both Vumerity and Tecfidera operate through conversion to monomethyl fumarate, which helps reduce MS-related inflammation and may provide neuroprotective effects. The new formulation maintains the established therapeutic efficacy while minimizing adverse gastrointestinal effects such as nausea, vomiting, diarrhea, and abdominal pain.

Commercial Significance

For Biogen, this approval represents a crucial development in their multiple sclerosis portfolio strategy. As Tecfidera faces increasing generic competition and declining sales, Vumerity is positioned as a key revenue driver. In the U.S. market, where Vumerity has been available since 2019, the drug generated $409 million in sales last year, while Tecfidera's sales decreased to $681 million from its 2019 peak of $3.3 billion.

The European approval in late 2022, followed by NICE's recommendation, opens new market opportunities for Biogen as they navigate the transition from Tecfidera to Vumerity in their multiple sclerosis treatment portfolio.