Biogen Presents Data Demonstrating Improved Gastrointestinal
Tolerability With VUMERITY™ (diroximel fumarate) Compared to
TECFIDERA® (dimethyl fumarate)
Biogen Inc. (Nasdaq: BIIB) today announced detailed results
from the Phase 3 EVOLVE-MS-2 study demonstrating the improved
patient-assessed gastrointestinal (GI) tolerability of VUMERITY™
(diroximel fumarate), a new FDA-approved treatment for relapsing
forms of multiple sclerosis (MS), compared to
TECFIDERA® (dimethyl fumarate). These EVOLVE-MS-2 results are
being presented at the 27th Annual Meeting of the European Charcot
Foundation in Italy (Nov. 21-23).
“We know that each patient’s journey can vary greatly in MS, so
Biogen aims to meet individual treatment goals through our broad MS
portfolio,” said Alfred Sandrock, Jr., M.D., Ph.D., Executive Vice
President, Research and Development, and Chief Medical Officer at
Biogen. “TECFIDERA is a clinically meaningful treatment for
patients, and we believe VUMERITY now builds upon our franchise as
another compelling option for relapsing MS.”
EVOLVE-MS-2 is the first study to directly compare the GI
tolerability of two relapsing MS treatments. In this study
involving relapsing-remitting MS (RRMS) patients, VUMERITY was
associated with significantly shorter duration, severity and daily
impact of five key GI symptoms, compared to TECFIDERA. Results for
the primary endpoint show patients treated with VUMERITY
self-reported 46 percent fewer days with intensity scores of ≥2 on
the Individual Gastrointestinal Symptom and Impact Scale (IGISIS),
compared to TECFIDERA (adjusted rate ratio [95% confidence
interval]: 0.54 [0.39−0.75], p = 0.0003). IGISIS is a novel and
exploratory scale used by patients in the study to self-assess the
intensity and duration of key GI symptoms, including nausea,
vomiting, upper and lower abdominal pain and diarrhea. Results
observed with TECFIDERA in EVOLVE-MS-2 are consistent with its
well-characterized safety profile.
The EVOLVE-MS-2 results also indicate that compared to
TECFIDERA, VUMERITY-treated patients had:
- Lower discontinuations due to GI adverse events (AEs) (0.8
percent vs. 4.8 percent).
- Fewer days with IGISIS intensity scores of ≥1 and ≥3 (29
percent relative reduction and 44 percent relative reduction,
respectively).
- Fewer days with a self-reported intensity score of ≥1 (30
percent reduction, on the Global Gastrointestinal Symptom and
Impact Scale (GGISIS), which assessed the overall intensity of GI
symptoms, their impact on daily activities and how bothersome they
were. Fewer days with GGISIS intensity scores of ≥2 and ≥3 were
also observed.
- A gradual decline in worst IGISIS intensity scores over the
five-week treatment period.
These findings using the patient-assessed symptom intensity
scales were supported by lower investigator-reported incidences of
GI AEs with VUMERITY (34.8 percent) compared to TECFIDERA (49.0
percent). Overall AEs occurred in 78.3 percent of patients with
VUMERITY and 83.7 percent with TECFIDERA. Most AEs were mild or
moderate in severity. The overall proportion of patients with AEs
leading to study discontinuation were 1.6 percent for VUMERITY and
5.6 percent for TECFIDERA.
EVOLVE-MS-2 was a multi-center, double-blind, active-controlled,
five-week Phase 3 study designed to evaluate the GI tolerability,
including duration and severity, of VUMERITY compared to TECFIDERA
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. Secondary endpoints
evaluated the number of days (relative to exposure) that patients
reported GI symptoms with an IGISIS intensity scores of ≥1 or ≥3 in
the overall population; IGISIS intensity score of ≥2 in patients
from Part B only; GGISIS intensity scores of ≥1, ≥2, or ≥3 in the
overall population; and worst (i.e., highest) IGISIS individual
symptom score by study week. Patients who completed the five-week
treatment period were eligible to enroll in EVOLVE-MS-1, a 96-week,
open-label, safety study for VUMERITY.
VUMERITY is now available in the U.S. for relapsing forms of
MS.
About VUMERITY™ (diroximel fumarate) VUMERITY
is a novel, oral fumarate with a distinct chemical structure
approved in the U.S. for the treatment of relapsing forms of
multiple sclerosis, to include clinically isolated syndrome,
relapsing-remitting disease and active secondary progressive
disease. Once in the body, VUMERITY rapidly converts to monomethyl
fumarate, the same active metabolite of dimethyl fumarate.
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 based 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 decrease in mean lymphocyte counts during the
first year of treatment, liver injury and flushing. The most common
adverse events, obtained using data from dimethyl fumarate (which
has the same active metabolite as VUMERITY), were flushing,
abdominal pain, diarrhea and nausea.
Please click here for Important Safety
Information and full Prescribing Information,
including Patient Information for VUMERITY in the
U.S.
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
415,000 patients have been treated with it, representing more than
780,000 patient-years of exposure across clinical trial use and
patients prescribed TECFIDERA. Of these, 6,335 patients (14,065
patient-years) were from clinical trials.1
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 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, liver injury and flushing. In clinical
trials, the most common adverse events associated with TECFIDERA
were flushing, abdominal pain, diarrhea and nausea
Please click here for Important Safety
Information and full Prescribing Information,
including Patient Information for TECFIDERA in the U.S.,
or visit your respective country’s product website.
About Biogen At 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. Today Biogen has the leading
portfolio of medicines to treat multiple sclerosis, has introduced
the first approved treatment for spinal muscular atrophy,
commercializes biosimilars of advanced biologics and is focused on
advancing research programs in multiple sclerosis and
neuroimmunology, neuromuscular disorders, movement disorders,
Alzheimer’s disease and dementia, ophthalmology, immunology,
neurocognitive disorders, acute neurology and pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media –
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Biogen Safe Harbor This 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 VUMERITY and TECFIDERA; results from the EVOLVE-MS-2
study; the treatment of MS; the potential of Biogen’s commercial
business, including VUMERITY and TECFIDERA; and risks and
uncertainties associated with drug development and
commercialization. These forward-looking statements may be
identified by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “except,” “forecast,” “goal,” “intend,” “may,”
“plan,” “possible,” “potential,” “will,” “would” 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
such statements, including without limitation the occurrence of
adverse safety events and/or unexpected concerns that may arise
from additional data or analysis; failure to obtain regulatory
approvals in other jurisdictions; risks of unexpected costs or
delays; unexpected concerns may arise from additional data,
analysis or results obtained during clinical trials; failure to
protect and enforce our data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; 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
our expectations in any forward-looking statement. Investors should
consider this cautionary statement, as well as the risk factors
identified in our most recent annual or quarterly report and in
other reports we have filed with the U.S. Securities and Exchange
Commission. These statements are based on our current beliefs and
expectations and speak only as of the date of this news release. We
do not undertake any obligation to publicly update any
forward-looking statements, whether as a result of new information,
future developments or otherwise.
MEDIA CONTACT:David
Caouette +1 617 679 4945public.affairs@biogen.com |
INVESTOR CONTACT:Joe Mara+1 781
464 2442 IR@biogen.com |
1 Combined post-marketing data based on prescriptions and
clinical trials exposure to TECFIDERA as of June 30, 2019.
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