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The most common adverse events (AEs) reported in the study for both treatment groups were flushing, diarrhea and nausea (32.8%, 15.4% and 14.6% for diroximel fumarate; 40.6%, 22.3% and 20.7% for dimethyl fumarate). The overall proportion of patients with AEs leading to study discontinuation were 1.6% for diroximel fumarate and 6.0% for dimethyl fumarate. Of those, the proportion of patients who discontinued due to GI adverse events during the five-week treatment period were 0.8% for diroximel fumarate and 4.8% for dimethyl fumarate. Further analysis of the data from the EVOLVE-MS-2 study is ongoing and will be presented at a future scientific forum.
"As part of our leadership in multiple sclerosis, Biogen has long understood that the disease differs from person to person, as well as throughout the course of the disease. We are committed to offering a range of options to patients to meet their needs," said
"Diroximel fumarate demonstrated statistically superior GI tolerability compared to dimethyl fumarate on the EVOLVE-MS-2 study's primary endpoint, as well as a low discontinuation rate of less than 1% due to GI adverse events. These results reinforce the safety and tolerability profile diroximel fumarate has consistently demonstrated across the EVOLVE-MS development program, underscoring the potential importance of diroximel fumarate for the treatment of people living with relapsing-remitting MS. We look forward to the
EVOLVE-MS-2 was a Phase 3, multicenter, double-blind, active-controlled, five-week study designed to evaluate the GI tolerability, including duration and severity, of diroximel fumarate 462 mg twice daily compared to dimethyl fumarate 240 mg twice daily in 506 patients with RRMS. The study's primary endpoint assessed the number of days patients reported GI symptoms with a symptom intensity score ≥2 on the IGISIS rating scale spanning 0 (not at all) through 10 (extreme). The IGISIS was completed twice daily and evaluated the intensity of key GI symptoms, including nausea, vomiting, upper and lower abdominal pain, and diarrhea.
"With a chronic disease like MS, interrupting or stopping treatment due to GI side effects can often provoke the return of disease activity. Physicians and patients should work together to choose a medication that provides the right balance of efficacy, safety and tolerability to help manage patients' MS and meet their treatment goals," said
The EVOLVE-MS-2 study is part of the EVOLVE-MS diroximel fumarate clinical development program, which is being conducted as part of a worldwide development and commercialization agreement between
About Diroximel Fumarate
Diroximel fumarate is an investigational, novel oral fumarate candidate with a distinct chemical structure in development for the treatment of relapsing forms of MS. Diroximel fumarate is designed to rapidly convert to monomethyl fumarate in the body and, based on bioequivalence data, is referencing TECFIDERA® (dimethyl fumarate) as part of the 505(b)(2) regulatory pathway. Diroximel fumarate is currently under review with the
About the Diroximel Fumarate EVOLVE-MS Clinical Development Program
The key components of the EVOLVE-MS (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis) clinical development program of diroximel fumarate include the EVOLVE-MS-1 study, a Phase 3, open-label, two-year safety study in relapsing-remitting MS patients, along with pharmacokinetic bridging studies comparing diroximel fumarate and dimethyl fumarate to demonstrate bioequivalence. The EVOLVE-MS clinical development program also includes EVOLVE-MS-2, a Phase 3, five-week randomized, prospective, double-blind, multi-center study assessing the GI tolerability of diroximel fumarate and dimethyl fumarate.
About Tecfidera® (dimethyl fumarate)
TECFIDERA is the most prescribed oral medication for relapsing multiple sclerosis (MS) in the world and has been shown to reduce the rate of MS relapses, slow the progression of disability and impact the number of MS brain lesions, while demonstrating a well-characterized safety profile in people with relapsing forms of MS. TECFIDERA is approved in 69 countries and more than 398,000 patients have been treated with it, representing more than 740,000 patient-years of exposure across clinical trial use and patients prescribed TECFIDERA. Of these, 6,335 patients (12,985 patient-years) were from clinical trials.[i] TECFIDERA is indicated in the U.S. for the treatment of patients with relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TECFIDERA is approved in the
TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Rare 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 patients in the setting of prolonged lymphopenia although the role of lymphopenia in these cases is uncertain. Other serious side effects include a decrease in mean lymphocyte counts during the first year of treatment, which then plateaued, and liver function abnormalities, which resolved upon treatment discontinuation. In clinical trials, the most common adverse events associated with TECFIDERA were flushing and gastrointestinal (GI) events.
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Alkermes Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the continued clinical development and the potential therapeutic and commercial value of diroximel fumarate for the treatment of relapsing forms of MS; plans for presentation of the EVOLVE-MS-2 data at an upcoming scientific forum; the timing and potential outcome of the
Biogen Safe Harbor
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential benefits, safety and efficacy of diroximel fumarate; potential clinical effects of diroximel fumarate; results from the EVOLVE-MS-2 study; the clinical development program for diroximel fumarate; potential regulatory approval and the timing thereof; clinical trial results and plans; Biogen's research and development program for the treatment of MS; the treatment of MS; the potential of Biogen's commercial business and pipeline programs, including diroximel fumarate; the anticipated benefits and potential of Biogen's collaboration arrangements with
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis; risks of unexpected costs or delays; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of Biogen's drug candidates, including diroximel fumarate; actual timing and content of submissions to and decisions made by the regulatory authorities regarding Biogen's drug candidates, including diroximel fumarate; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including diroximel fumarate; unexpected concerns may arise from additional data, analysis or results obtained during clinical trials; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; uncertainty of success in the development and potential commercialization of VUMERITY; risks relating to the potential launch of VUMERITY, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for VUMERITY and other unexpected difficulties or hurdles; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the
TECFIDERA® is a registered trademark of Biogen Inc.; VUMERITY™ is a trademark of
[i] Combined post-marketing data based on prescriptions and clinical trials exposure to TECFIDERA as of
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