World News: 10:00 GMT Wednesday 11th September 2019. [Biogen Inc. via Globe Newswire via SPi World News]
CAMBRIDGE, Mass., Sept. 11, 2019 (GLOBE NEWSWIRE) -- (Nasdaq: BIIB) announced new data to support the consistent, long-term benefits of treatment with TECFIDERA (dimethyl fumarate) over 10 years, as well as additional diroximel fumarate data that further characterize the tolerability profile of this investigational oral fumarate for relapsing multiple sclerosis (MS). These findings are being presented at the 35 Congress of the European Committee for Treatment and Research in MS (ECTRIMS) and 24 Annual Conference of Rehabilitation in MS in Stockholm (September 11-13).
“Biogen’s new data underscore TECFIDERA’s role as a meaningful long-term therapy option for relapsing MS, with many patients in the study experiencing no relapses or progression in their disability over a 10-year period,” said Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen. “We are proud of the strong legacy TECFIDERA has achieved over the years and are excited to continue building our franchise of fumarate products with the potential addition of diroximel fumarate. As a next-generation fumarate, diroximel fumarate offers a differentiated gastrointestinal tolerability profile and, if approved, will be a strong choice for physicians and patients with relapsing MS to consider.”
Separately, a meta-analysis of real-world evidence to compare the effectiveness of TECFIDERA versus other disease-modifying therapies for relapsing MS is also being presented. The meta-analysis analyzed data from 18 databases of large real-world studies and found that TECFIDERA was significantly more effective than interferon beta, glatiramer acetate and teriflunomide in reducing annualized relapse rate and delaying time to first relapse. TECFIDERA demonstrated comparable effectiveness to fingolimod and was less effective than natalizumab and alemtuzumab. These results are consistent with previously reported comparative effectiveness data and reinforce the strong efficacy of TECFIDERA over platform treatments across multiple data sets.
In the study, most adverse events were mild to moderate in nature. The overall rate of treatment discontinuation due to adverse events was low (7.1 percent), with less than 1 percent of patients discontinuing diroximel fumarate treatment due to gastrointestinal (GI) side effects. These data are further supportive of recently reported topline results from the elective Phase 3 EVOLVE-MS-2 study, in which diroximel fumarate demonstrated statistically superior GI tolerability compared to TECFIDERA on the study’s primary endpoint assessing self-reported GI events.
Exploratory efficacy results from EVOLVE-MS-1 suggest diroximel fumarate significantly reduced annualized relapse rate by 79.4 percent and the mean number of gadolinium-enhancing lesions by 64.3 percent from baseline to 24 months, with similar results observed in newly diagnosed patients.
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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_________________________ Combined post-marketing data based on prescriptions and clinical trials exposure to TECFIDERA as of June 30, 2019.
Globe Newswire: 10:00 GMT Wednesday 11th September 2019
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