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Biogen’s Vumerity recommended by CHMP in MS

A thumbs up for Vumerity in the EU could ease the way for Biogen’s follow-up to Tecfidera in multiple sclerosis

The Committee for Medicinal Products for Human Use (CHMP) has recommended Vumerity (diroximel fumarate) for patients with relapsing-remitting multiple sclerosis (RRMS) in the European Union.

Vumerity is a next-generation oral fumarate that has the same active ingredient as Biogen’s blockbuster MS drug Tecfidera (dimethyl fumarate), which faces generic competition.

The active ingredient, monomethyl fumarate, reduces the rate of MS relapses, slows the progression of disability and impacts the number of MS brain lesions. Approved in 69 countries, Tecfidera is the most prescribed oral medication for relapsing MS in the world, with more than 500,000 patients treated.

The CHMP positive opinion is based on the well-established long-term safety and efficacy profile of Tecfidera plus data from pharmacokinetic bridging studies comparing the two drugs. The phase 3 EVOLVE-MS-2 study, which evaluated the gastrointestinal tolerability of Vumerity compared to Tecfidera, found treatment discontinuation was lower with the new drug – only 1.6% of patient discontinued treatment due to adverse events compared to 6% of patients receiving Tecfidera.

Vumerity has been available in the US for nearly two years, after gaining approval from the Food and Drug Administration for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease. Vumerity has since overtaken Tecfidera to become the number one prescribed oral MS therapy in the country.

An estimated 2.8 million people live with MS across the globe, with some European countries demonstrating the highest prevalence.

“With MS, finding the right treatment option is as much about managing the clinical aspects of the disease as it is about how treatment fits into a person’s life,” said Simon Faissner, assistant professor in neurology at Germany’s Ruhr-University Bochum. He added that the CHMP opinion was “a crucial step forward” in oral therapeutic options in MS that were “easy to integrate into a patient’s daily life”.

Biogen has worked in MS for more than 25 years. In July this year, the company signed a deal with InnoCare Pharma for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) to treat MS, allowing Biogen to expand its MS pipeline portfolio. The drug is currently marketed for different types of cancer in the US and China.

In 2020, Biogen reported sales of $3.84bn of Tecfidera but the past year has seen its revenues drop, with GlobalData forecasting that Tecfidera will only generate $1.12bn in 2026 due to generic competition.

Article by
Hugh Gosling

20th September 2021

From: Research, Regulatory, Healthcare



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