The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis

  • VUMERITY is a next-generation oral fumarate treatment for people with relapsing-remitting MS with established efficacy and well-characterized safety, building on Biogen’s leadership in MS oral therapies
  • Phase 3 data have demonstrated that treatment with VUMERITY results in low discontinuation rates due to its gastrointestinal (GI) tolerability profile
  • European Union authorization follows approvals in United States, Great Britain and Switzerland, providing patients another important option as they consider treatment initiation in the context of COVID-19

Biogen moment blazoned that the European Commission (EC) has granted marketing authorization for VUMERITY ® (diroximel fumarate) to treat grown-ups with relapsing- remitting multiple sclerosis (MS). VUMERITY is a coming- generation fumarate that offers the convenience of an oral drug with the established efficacity and well- characterized safety of TECFIDERA ® (dimethyl fumarate). Encyclopedically, an estimated2.8 million people live with MS, with further than 1 million people in Europe living with the complaint
“ The blessing of VUMERITY provides a new oral treatment option with low gastrointestinal termination rates that may help cases to start and cleave to treatment,” said Simon Faissner,M.D., PhD, Assistant Professor at the Department of Neurology, Ruhr-University Bochum. “ This drug allows for MS cases in the EU to be treated without having to suppose about salutary restrictions or when to take a cure in relation to mealtimes which, when treating a habitual complaint, may give cases with fresh inflexibility in their diurnal lives.”
The EC’s blessing of VUMERITY is grounded on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and reckoned in part on the well- established long- term efficacity and safety profile of TECFIDERA. The blessing was also grounded on findings from EVOLVE-MS-2, a large, randomized, double-eyeless, five-week,multi-center Phase 3 study to estimate the gastrointestinal (GI) tolerability of VUMERITY compared to TECFIDERA in cases with relapsing- remittingMS. In EVOLVE-MS-2, the rate of overall treatment termination was lower in actors treated with VUMERITY compared to those treated with TECFIDERA (1.6 compared to 6, independently). The difference in the termination rates due to GI tolerability was0.8 for VUMERITY compared to4.8 for TECFIDERA. Also, flushing was reported in32.8 of VUMERITY- treated cases and in40.6 of TECFIDERA treated cases. There were no serious events of flushing or expirations due to flushing in the study.

“ This blessing is a significant step forward in perfecting treatment adherence for people living with returning MS, which can make a meaningful difference on treatment issues impacting their diurnal lives,” said Maha Radhakrishnan,M.D., Chief Medical Officer at Biogen.
About VUMERITY ® (diroximel fumarate)
VUMERITY is an oral fumarate with a distinct chemical structure from TECFIDERA (dimethyl fumarate), approved in theU.S. for the treatment of returning forms of multiple sclerosis in grown-ups, to include clinically insulated pattern, relapsing- remitting complaint and active secondary progressive complaint. Formerly in the body, VUMERITY fleetly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate furnishing analogous efficacity and safety biographies.

VUMERITY is contraindicated in cases with known acuity to diroximel fumarate, dimethyl fumarate or to any of the excipients of VUMERITY; and in cases taking dimethyl fumarate. Serious side goods for VUMERITY are grounded on data from dimethyl fumarate (which has the same active metabolite as VUMERITY) and include anaphylaxis and angioedema, progressive multifocal leukoencephalopathy, which is a rare opportunistic viral infection of the brain that has been associated with death or severe disability, a drop in mean lymphocyte counts during the first time of treatment, herpes zoster and other serious infections, liver injury and flushing. The most common adverse events, attained using data from dimethyl fumarate (which has the same active metabolite as VUMERITY), were flushing, abdominal pain, diarrhea and nausea.

About TECFIDERA ® (dimethyl fumarate)
TECFIDERA, a treatment for returning forms of multiple sclerosis (MS) in grown-ups, is the most prescribed oral drug for returning MS in the world and has been shown to reduce the rate of MS relapses, decelerate the progression of disability and impact the number of MS brain lesions, while demonstrating a well- characterized safety profile in people with relapsing forms ofMS. TECFIDERA is approved in 69 countries, and further than cases have been treated with it, representing further than case- times of exposure across clinical trial use and cases specified TECFIDERA.4
TECFIDERA is contraindicated in cases with a known acuity to dimethyl fumarate or any of the excipients of TECFIDERA. Serious side goods include anaphylaxis and angioedema, and cases of progressive multifocal leukoencephalopathy, a rare opportunistic viral infection of the brain which has been associated with death or severe disability, have been seen with TECFIDERA cases in the setting of prolonged lymphopenia although the part of lymphopenia in these cases is uncertain. Other serious side goods include a drop in mean lymphocyte counts during the first time of treatment, herpes zoster and other serious infections, liver injury and flushing. In clinical trials, the most common adverse events associated with TECFIDERA were flushing, abdominal pain, diarrhea and nausea.

About Biogen
As settlers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative curatives for people living with serious neurological conditions as well as affiliated remedial closeness. One of the world’s first global biotechnology companies, Biogen was innovated in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Moment, Biogen has the leading portfolio of drugs to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is furnishing the first and only approved treatment to address a defining pathology of Alzheimer’s complaint. Biogen is also commercializing biosimilars and fastening on advancing the assiduity’s most diversified channel in neuroscience that will transfigure the standard of care for cases in several areas of high unmet need.

Source link: