MHRA Grants Marketing Authorization for Biogen’s MS Treatment

Biogen received MHRA marketing authorization for VUMERITY (diroximel fumarate) for treatment of relapsing-remitting multiple sclerosis (RRMS).

The United Kingdom’s regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), has granted marketing authorization for Biogen’s VUMERITY (diroximel fumarate) as an oral treatment for relapsing-remitting multiple sclerosis (RRMS).

According to a Nov. 18, 2021 press release, the authorization by MHRA, which comes shortly after that of the European Commission (EC), has been based on data from pharmacokinetic bridging studies comparing diroximel fumarate and dimethyl fumarate, as well as data from clinical trials assessing the tolerability, safety, and efficacy of the therapy in RRMS patients. Diroximel fumarate has already been approved by the US FDA in October 2019.

“Everyone’s experience of MS is unique, it can be unpredictable and emotionally and physically challenging,” said Dr Mihaela Vlaicu, head of Medical Affairs, Biogen UK and Ireland, in the press release. “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.”

“The approval of diroximel fumarate by the MHRA, and [previously] by the EC, highlights the importance of treatment adherence, which can make a meaningful difference on treatment outcomes when living with a chronic disease,” added Jonathan Randell, senior director, Value & Access, Biogen UK and Ireland, in the press release. “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 and Ireland.”

Source: Biogen UK