VUMERITY may be a next-generation oral fumarate with a well-characterized efficacy and safety profile
Data from the Phase 3 EVOLVE-MS-2 study have demonstrated that treatment with VUMERITY leads to low discontinuation rates thanks to its gastrointestinal (GI) tolerability profile
Upon approval, VUMERITY will offer a replacement oral option for MS patients as they consider treatment initiation within the context of the COVID-19 environment
Medicinal Products for Human Use (CHMP), a part of the ecu Medicines Agency (EMA), issued a positive opinion and has recommended granting marketing authorization for VUMERITY® (diroximel fumarate) within the European Union (EU). VUMERITY may be a next-generation oral fumarate for the treatment of adults with relapsing-remitting MS (RRMS). An estimated 2.8 million people accept MS across the world , with some European countries demonstrating the very best prevalence of MS within the world.1
“With MS, finding the proper treatment option is the maximum amount about managing the clinical aspects of the disease because it is about how treatment fits into a person’s life,” said Simon Faissner, M.D., PhD, professor at the Department of Neurology, Ruhr-University Bochum. “Today’s CHMP opinion may be a crucial breakthrough in providing an oral therapeutic option that’s easy to integrate into a patient’s lifestyle , which helps with ongoing care management.”
The CHMP’s positive opinion will now be mentioned the ecu Commission (EC), which grants marketing authorizations for medicines in Europe.
“We anticipate to advancing Biogen’s portfolio and continuing to figure with the MS community to deal with critical treatment challenges, including people who affect persistence and adherence to medication for this chronic and life-long disease,” said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. “VUMERITY builds on our experience in MS and therefore the established profile of TECFIDERA to bring a replacement oral option at a time when people with MS are making treatment decisions while considering other factors associated with their ongoing care during the pandemic.”
The positive CHMP opinion was supported data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to determine bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied partially on the well-established long-term safety and efficacy profile of TECFIDERA. The CHMP also assessed findings from EVOLVE-MS-2, a large, randomized, double-blind, five-week, multi-center Phase 3 study to guage the gastrointestinal (GI) tolerability of VUMERITY compared to TECFIDERA in patients with RRMS. In EVOLVE-MS-2, the speed of overall treatment discontinuation was lower in participants treated with VUMERITY compared to those treated with TECFIDERA (1.6% compared to six , respectively). The difference within the discontinuation rates thanks to GI tolerability was 0.8% for VUMERITY compared to 4.8% for TECFIDERA.
VUMERITY was first approved by the U.S. Food and Drug Administration in October 2019 and is currently the amount one prescribed oral MS therapy within the country. Since its launch within the U.S., real-world data have reinforced the positive GI tolerability profile of VUMERITY and confirmed that the experience demonstrated in clinical trials is according to clinical practice.2 Biogen continues to file regulatory submissions in other countries.
About VUMERITY® (diroximel fumarate)
VUMERITY is an oral fumarate with a definite chemical structure from TECFIDERA® (dimethyl fumarate), approved within the U.S. for the treatment of relapsing sorts of MS in adults, to incorporate clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Once within the body, VUMERITY rapidly converts to monomethyl fumarate, an equivalent active metabolite of dimethyl fumarate providing similar efficacy and safety profiles.
VUMERITY is contraindicated in patients with known hypersensitivity to diroximel fumarate, dimethyl fumarate or to any of the excipients of VUMERITY; and in patients taking dimethyl fumarate. Serious side effects for VUMERITY are supported data from dimethyl fumarate (which has an equivalent active metabolite as VUMERITY) and include anaphylaxis and angioedema, progressive multifocal leukoencephalopathy, which may be a rare opportunistic virus infection of the brain that has been related to death or severe disability, a decrease in mean lymphocyte counts during the primary year of treatment, herpes zoster and other serious infections, liver injury and flushing. the foremost common adverse events, obtained using data from dimethyl fumarate (which has an equivalent active metabolite as VUMERITY), were flushing, abdominal pain, diarrhea and nausea.
About TECFIDERA® (dimethyl fumarate)
TECFIDERA, a treatment for relapsing sorts of MS (MS) in adults, is that the most prescribed oral medication for relapsing MS within the world and has been shown to scale back the speed of MS relapses, slow the progression of disability and impact the amount of MS brain lesions, while demonstrating a well-characterized safety profile in people with relapsing sorts of MS. TECFIDERA is approved in 69 countries, and quite 500,000 patients are treated with it, representing quite 1,000,000 patient-years of exposure across clinical test use and patients prescribed TECFIDERA. Of these, 6,335 patients (14,241 patient-years) were from clinical trials.3
TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Serious side effects include anaphylaxis and angioedema, and cases of progressive multifocal leukoencephalopathy, a rare opportunistic virus infection of the brain which has been related to death or severe disability, are seen with TECFIDERA patients within the setting of lymphopenia. Other serious side effects include a decrease in mean lymphocyte counts during the primary year of treatment, herpes zoster and other serious infections, liver injury and flushing. In clinical trials, the foremost common adverse events related to TECFIDERA were flushing, abdominal pain, diarrhea and nausea.
For information on TECFIDERA prescribing information within the EU, please visit: https://www.ema.europa.eu/en/medicines/human/EPAR/tecfidera. Please click here for Important Safety Information and full Prescribing Information, including Patient Information for TECFIDERA within the U.S., or visit your respective country’s product website.
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