New Phase 3 Interim Results Support Safety and Efficacy of Diroximel Fumarate in Multiple Sclerosis
May 30 2019 - 7:30AM
Biogen Inc. (Nasdaq: BIIB) announced today new interim data
from the ongoing open-label, pivotal EVOLVE-MS-1 study indicate
that the investigational treatment diroximel fumarate was generally
well tolerated in people with relapsing multiple sclerosis (MS).
These results were presented at the annual meeting of the
Consortium of Multiple Sclerosis Centers (CMSC) in Seattle (May
28–June 1). Diroximel fumarate, a novel oral fumarate candidate in
development with Alkermes plc (Nasdaq: ALKS), is under review with
the U.S. Food and Drug Administration with a PDUFA (Prescription
Drug User Fee Act) target action date in the fourth quarter of
2019. Biogen intends to market diroximel fumarate under the
conditionally approved brand name VUMERITY™.
“The results we are presenting at CMSC add to the body of
evidence supporting the tolerability of diroximel fumarate and its
potential effectiveness in relapsing MS patient populations,
including newly diagnosed and early switch patients,” said Michael
Ehlers, executive vice president, research & development at
Biogen. “We are excited about these data for diroximel fumarate and
believe this distinct oral fumarate has the potential to be a
meaningful treatment option for people living with MS.”
EVOLVE-MS-1 is an ongoing, single-arm, open-label, two-year,
Phase 3 study evaluating the safety and exploring the efficacy of
diroximel fumarate in patients with relapsing-remitting MS. The
study plans to enroll approximately 1,000 patients. Interim results
from 696 patients treated with diroximel fumarate for a median of
approximately one year were presented in safety and efficacy
analyses at the CMSC meeting.
Researchers explored the efficacy of diroximel fumarate in a
sub-group analysis of EVOLVE-MS-1 that included patients naive to
prior disease-modifying therapy treatment or those previously
treated with an interferon (IFN) or glatiramer acetate (GA). New
results in patients treated with prior IFN/GA showed that diroximel
fumarate was associated with significant improvements in
radiological and clinical endpoints over one year compared to
baseline. Adjusted annualized relapse rate was reduced by 72
percent with diroximel fumarate between baseline and Week 48.
Additionally, the mean number of gadolinium-enhancing (Gd+) lesions
was reduced by 64 percent with diroximel fumarate compared to
baseline, and the percentage of patients with no Gd+ lesions at
Week 48 was 89 percent compared to 74 percent at baseline.
Additional new data illustrate the tolerability profile of
diroximel fumarate in relapsing-remitting MS patients over one
year. In the study, diroximel fumarate demonstrated low rates of
gastrointestinal (GI) adverse events leading to discontinuation
(0.7 percent). The incidence of GI adverse events in patients
treated with diroximel fumarate over the one-year treatment period
was 30.9 percent. The GI events were generally mild or moderate in
severity, typically appeared within the first month of treatment
and tended to resolve quickly in the vast majority (89 percent) of
patients.
The data presented at CMSC add to the current knowledge base of
diroximel fumarate and the interim results Biogen shared at the
American Academy of Neurology annual meeting earlier this month
(May 4–10) on the potential safety and effectiveness of diroximel
fumarate in relapsing MS, particularly in newly diagnosed patients.
In addition, the GI tolerability of diroximel fumarate as compared
to dimethyl fumarate is being evaluated in the ongoing EVOLVE-MS-2
study, with results expected later this year.
Featured Data Presentation Details:
- Tolerability of Diroximel Fumarate in Patients with
Relapsing-Remitting MS: Analysis of Gastrointestinal and Flushing
Events in the Phase 3 EVOLVE-MS-1 Study – Poster DXT41 -- Thursday,
May 30, 6:30 – 7:30 p.m. PT
- Efficacy of Diroximel Fumarate in Relapsing-Remitting MS
Patients Who Are Newly Diagnosed or Previously Treated with
Interferons or Glatiramer Acetate – Poster DXT42 – Thursday, May
30, 6:30 – 7:30 p.m. PT
About Diroximel FumarateDiroximel fumarate is a
novel oral fumarate candidate in development for the treatment of
relapsing forms of MS with a distinct chemical structure. Diroximel
fumarate is designed to rapidly convert to monomethyl fumarate in
the body and it is hypothesized that it may have the potential to
offer differentiated gastrointestinal (GI) tolerability as compared
to dimethyl fumarate. Alkermes is conducting the EVOLVE-MS-2 study
in patients with relapsing-remitting MS, a five-week, head-to-head
study versus dimethyl fumarate to evaluate GI tolerability in
addition to the EVOLVE-MS-1 study. Diroximel fumarate is currently
under review with the U.S. Food and Drug Administration (FDA) with
a PDUFA (Prescription Drug User Fee Act) target action date in the
fourth quarter of 2019. Diroximel fumarate will be marketed under
the brand name VUMERITYTM, which has been conditionally accepted by
the FDA and will be confirmed upon approval.
About BiogenAt Biogen, our mission is clear: we
are pioneers in neuroscience. Biogen discovers, develops and
delivers worldwide innovative therapies for people living with
serious neurological and neurodegenerative diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners
Walter Gilbert and Phillip Sharp, and today has the leading
portfolio of medicines to treat multiple sclerosis, has introduced
the first and only approved treatment for spinal muscular atrophy
and is focused on advancing neuroscience research programs in MS
and neuroimmunology, Alzheimer’s disease and dementia, movement
disorders, neuromuscular disorders, acute neurology, neurocognitive
disorders, pain and ophthalmology. Biogen also commercializes
biosimilars of advanced biologics.
We routinely post information that may be important to investors
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Biogen Safe HarborThis news 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; results from the EVOLVE-MS-1 study;
the clinical development program for diroximel fumarate, including
the enrollment of the EVOLVE-MS-1 study; potential regulatory
approval and the timing thereof; clinical trial results and plans;
our research and development program for the treatment of MS; the
identification and treatment of MS; the potential of our commercial
business and pipeline programs, including diroximel fumarate; the
anticipated benefits and potential of our collaboration
arrangements with Alkermes; and risks and uncertainties associated
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and other words and terms of similar meaning. Drug development and
commercialization involve a high degree of risk, and only a small
number of research and development programs result in
commercialization of a product. Results in early stage clinical
trials may not be indicative of full results or results from later
stage or larger scale clinical trials and do not ensure regulatory
approval. You should not place undue reliance on these statements
or the scientific data presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
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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
our drug candidates, including diroximel fumarate; actual timing
and content of submissions to and decisions made by the regulatory
authorities regarding our drug candidates, including diroximel
fumarate; regulatory submissions may take longer or be more
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refuse to approve or may delay approval of our drug candidates,
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