New Data at ECTRIMS 2021 Highlight Biogen’s Focus on
Patient-Centered Outcomes and Improving the MS Patient
Experience
Biogen Inc. (Nasdaq: BIIB) today announced new data from its
industry-leading portfolio of multiple sclerosis (MS) therapies.
These data include additional results from the NOVA study on the
efficacy of every six-week (Q6W) 300mg natalizumab intravenous (IV)
administration, results from a comparative real-world evaluation of
TYSABRI® (natalizumab) when compared to Ocrevus®(ocrelizumab), as
well as outcomes on GI tolerability, persistence and adherence for
VUMERITY® (diroximel fumarate). The studies are being presented at
the 37th Congress of the European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October
13-15, 2021.
“Our focus on improving the MS patient experience continues to
shape research initiatives across Biogen’s MS portfolio, as
demonstrated by presentations at this year’s ECTRIMS meeting,” said
Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “These
new data build upon the existing body of real-world safety and
efficacy evidence for extended interval dosing with
natalizumab1,2,3 and highlight outcomes that are important to
patients, including a reduced risk of relapse with TYSABRI and new
data on the ability for patients to achieve and maintain an
improved gastrointestinal tolerability profile with VUMERITY.”
Additional Secondary Endpoints and Exploratory Outcomes
from Full NOVA Study Include Evaluation of NEDA and EDSS With Q6W
NatalizumabNew late-breaking data from the Phase 3b NOVA
study provide additional insights into the efficacy of every
six-week (Q6W) 300mg natalizumab IV administration compared to the
approved every four-week (Q4W) dose of TYSABRI (n=499) for
relapsing-remitting multiple sclerosis. Topline results from the
NOVA study were released in August 2021, showing that every
six-week administration provides a high level of efficacy in
controlling MS disease activity in patients who switched to Q6W
after at least one year of disease stability on the approved Q4W IV
dosing schedule. New results of exploratory outcomes and additional
secondary endpoints presented at ECTRIMS demonstrate that efficacy
is maintained on a Q6W schedule:
- Time to first relapse was similar between the two dosing
schedules with the proportion who were relapse-free at 72 weeks at
96.9 percent for Q6W and 97.6 percent for Q4W.
- The proportion of patients free of disability worsening was
90.0 percent in the Q6W arm and 92.0 percent in the Q4W arm.
- Disease activity rates were similar between both groups. The
proportion of patients with No Evidence of Disease Activity (NEDA)
was 70.0 percent for Q6W and 67.4 percent for Q4W. NEDA was defined
as no gadolinium enhancing (Gd+) lesions, no new or newly enlarging
T2 hyperintense lesions, no relapse and no 24-week confirmed
disability worsening (CDW) at 72 weeks. Patients with one or more
missing assessments were counted as having not achieved NEDA.
- The safety findings in the NOVA study were consistent with the
known safety profile of IV natalizumab, and the incidence of AEs
and SAEs were similar between the two treatment arms. One patient
with asymptomatic progressive multifocal leukoencephalopathy (PML)
in the Q6W arm was high-risk based on the known risk factors,
underscoring the importance of the need for continued PML
monitoring and risk factor considerations in patients treated
with natalizumab.
“Upon complete evaluation of the NOVA data, the results
inclusive of secondary and exploratory outcomes offer a more
comprehensive understanding of the six-week dosing regimen of
natalizumab and its ability to provide a high level of efficacy in
controlling MS disease activity,” said John Foley, M.D., Rocky
Mountain MS Clinic. “Combined with the improvement in safety
demonstrated through analyses of data from the TOUCH Prescribing
Program, which has shown that a six-week dosing schedule is
associated with an 88 percent reduction in the risk of PML4, these
data on the efficacy of every six-week dosing offer valuable
information for clinicians.”
The NOVA study was designed to assess the efficacy of Q6W dosing
with natalizumab IV administration following analyses from the
TOUCH (TYSABRI Outreach: Unified Commitment to Health)
Prescribing Program, which showed that extended interval dosing was
associated with a significant reduction in the probability of PML.4
Natalizumab is available commercially under the brand name TYSABRI
and the only approved dose is 300mg on a Q4W regimen.
A Real-world Analysis Reports Lower Relapse Risk With
TYSABRI Than OcrevusA new analysis of relapse-related
outcomes and healthcare utilization for MS patients being treated
with disease-modifying therapies (DMTs) found that those treated
with TYSABRI (n=835) had a lower risk of relapse than those treated
with Ocrevus (n=3,497). The retrospective analysis of data from a
U.S. claims database from April 2017 to September 2020 found:
- The probability of remaining free of any relapse was
significantly higher with TYSABRI than with Ocrevus at 12 and 24
months (p<0.001);
- Time to first relapse significantly favored TYSABRI over
Ocrevus for any relapse (hazard ratio [HR]=0.70; p<0.01) and
outpatient relapse (HR=0.71; p<0.01);
- Time to hospitalized relapse was numerically better for TYSABRI
compared to Ocrevus but did not differ significantly between
treatments (HR=0.61; p=0.11);
- There were no significant differences in annualized costs for
relapse-related hospital encounters or steroid use observed between
the two treatments and time to first MS-related ER visit did not
differ significantly between treatments (HR=1.05; p=0.81).
New EVOLVE-MS-2 Study Results Suggest Consistent GI
Tolerability for VUMERITY Throughout Dose Titration May Prevent
Delays in Reaching Maintenance DoseIn the Phase 3
EVOLVE-MS-2 study, VUMERITY (n=253) demonstrated that an improved
GI tolerability profile compared to TECFIDERA® (dimethyl fumarate)
(n=251) may simplify initiation of therapy. A new analysis
presented at the meeting examines GI tolerability during the dose
titration period and during the maintenance dose period over the
course of the study for individuals starting therapy on VUMERITY
relative to TECFIDERA. In addition to reinforcing VUMERITY’s
tolerability profile based on less frequent and less severe GI
events versus TECFIDERA, key findings include:
- Weekly incidence of GI adverse events (AEs) remained consistent
and low throughout the 5-week treatment period for VUMERITY but
increased in number and severity for TECFIDERA after titration to
the full dose, peaking in Weeks 3 and 4.
- Throughout the 5-week treatment period, moderate/severe GI AEs
were less likely with VUMERITY (1.6%–4.8% versus 4.4%–13.9% with
TECFIDERA).
- Discontinuations due to GI AEs were 0.8 percent for VUMERITY
and 4.8 percent for TECFIDERA; most TECFIDERA discontinuations
occurred in Week 3 (58.3 percent)
“These findings suggest GI tolerability is consistent across the
doses with VUMERITY, which may enable patients to potentially reach
the maintenance dose with less dose interruptions,” said Robert
Naismith, M.D., of Washington University School of Medicine.
“Reducing the need for physicians to utilize real-world GI
mitigation strategies has the potential to have a positive impact
on treatment compliance and adherence.”
Data Presentations Featured at ECTRIMS:
- Primary Results of NOVA: A Randomised Controlled Study of the
Efficacy of 6-Week Dosing of Natalizumab Versus Continued 4-Week
Treatment for Multiple Sclerosis (P970)
- Claims-based Relapse and Hospitalisation Rates in Patients With
Multiple Sclerosis Treated With Natalizumab or Ocrelizumab
(P833)
- Comparing the Impact of Dose Titration on Gastrointestinal
Tolerability: Diroximel Fumarate Versus Dimethyl Fumarate in
Patients With Relapsing-Remitting Multiple Sclerosis (P692)
About TYSABRI®
(natalizumab) TYSABRI is a well-established
treatment indicated for relapsing forms of multiple sclerosis (MS)
in adults that has been proven in clinical trials to slow physical
disability progression, reduce the formation of new brain lesions
and cut relapses. In the U.S., TYSABRI is indicated as monotherapy
for the treatment of patients with relapsing forms of MS. In the
European Union, it is indicated as a single disease-modifying
treatment (DMT) in adults with highly active relapsing-remitting MS
(RRMS) for patients with highly active disease activity despite a
full and adequate course of treatment with at least one DMT or
patients with rapidly evolving severe RRMS. TYSABRI is approved in
over 80 countries, and approximately 233,000 people worldwide have
been treated with TYSABRI, with over 927,000 patient-years of
experience, based on clinical trials and prescription data.5
TYSABRI increases the risk of progressive multifocal
leukoencephalopathy (PML), a rare opportunistic viral infection of
the brain which has been associated with death or severe
disability. Risk factors that increase the risk of PML are the
presence of anti-JCV antibodies, prior immunosuppressant use and
longer TYSABRI treatment duration. Patients who have all three risk
factors have the highest risk of developing PML. When initiating
and continuing treatment with TYSABRI, physicians should consider
whether the expected benefit of TYSABRI is sufficient to offset
this risk.
TYSABRI also increases the risk of developing encephalitis and
meningitis caused by herpes simplex and varicella zoster viruses,
and serious, life-threatening and sometimes fatal cases have been
reported in the post-marketing setting in MS patients receiving
TYSABRI. Clinically significant liver injury, including acute liver
failure requiring transplant, has also been reported in the
post-marketing setting. Other serious adverse events that have
occurred in TYSABRI-treated patients include hypersensitivity
reactions (e.g., anaphylaxis), and infections including
opportunistic infections, and a reduction in blood platelet
counts.
Please click here for Important Safety Information,
including Boxed Warning, and full Prescribing Information,
including Medication Guide for TYSABRI in the U.S., or
visit your respective country’s product website.
About
VUMERITY® (diroximel
fumarate)VUMERITY is an oral fumarate with a distinct
chemical structure from TECFIDERA® (dimethyl fumarate), approved in
the U.S. for the treatment of relapsing forms of multiple sclerosis
in adults, 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, herpes zoster and other serious
infections, 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, a treatment for relapsing forms
of multiple sclerosis (MS) in adults, is the most prescribed oral
medication for relapsing 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
530,000 patients have been treated with it, representing more than
1,000,000 patient-years of exposure across clinical trial use and
patients prescribed TECFIDERA.6
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, herpes zoster and other serious
infections, 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 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. 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, Alzheimer’s disease and dementia, neuromuscular
disorders, movement disorders, ophthalmology, neuropsychiatry,
immunology, acute neurology and neuropathic 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 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, about the potential benefits, safety and
efficacy of TYSABRI (natalizumab), VUMERITY and Q6W; the results of
the NOVA Phase 3b study, the results of the EVOLVE-MS-2 study and
certain real-world data; clinical trials and data readouts and
presentations; and the treatment of MS. These forward-looking
statements may be identified by words such as “aim,” “anticipate,”
“believe,” “could,” “estimate,” “expect,” “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 uncertainty of
success in the development and potential commercialization of Q6W;
unexpected concerns that may arise from additional data, analysis
or results obtained during the NOVA Phase 3b study, the EVOLVE-MS-2
study or other clinical studies of TYSABRI (natalizumab), VUMERITY
and Q6W; the occurrence of adverse safety events and/or unexpected
concerns that may arise from additional data or analysis;
regulatory authorities may require additional information or
further studies, or may fail or refuse to approve or may delay
approval of expansion of product labeling; risks of unexpected
costs or delays; 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 the direct and indirect
impacts of the ongoing COVID-19 pandemic on our business, results
of operations and financial condition. 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.
References:
- Chisari et al. Clinical effectiveness of different natalizumab
interval dosing schedules in a large Italian population of patients
with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2020;0:1–7.
doi: 10.1136/jnnp-2020-323472.
- Butzkueven H et al. Similar Clinical Outcomes for Natalizumab
Patients Switching to Every-6-Week Dosing Versus Remaining on
Every-4-Week Dosing in Real-World Practice. Poster presented at 8th
Joint ACTRIMS-ECTRIMS Virtual Meeting; September 11–13, 2020.
P0393.
- Zhovtis Ryerson L et al. No Difference in Radiologic Outcomes
for Natalizumab Patients on Extended Interval Dosing Compared with
Standard Interval Dosing in MS PATHS. Poster presented at American
Academy of Neurology Virtual Annual Meeting; April 17-22,2021.
P15.210.
- Zhovtis Ryerson et al. Natalizumab Extended Interval Dosing
(EID) is Associated with a Reduced Risk of Progressive Multifocal
Leukoencephalopathy (PML) Compared with Every-4-week (Q4W) Dosing:
Updated Analysis of the TOUCH® Prescribing Program Database. Poster
presented at American Academy of Neurology Virtual Annual Meeting;
April 17-22, 2021.P15.201
- Combined post-marketing data based on prescriptions and
clinical trials exposure to TYSABRI as of July 31, 2021.
- Combined post-marketing data based on prescriptions and
clinical trials exposure to TECFIDERA as of June 30, 2021.
MEDIA CONTACT:Ashleigh Koss+ 1 908 205
2572public.affairs@biogen.com |
INVESTOR CONTACT:Mike Hencke+1 781 464 2442IR@biogen.com |
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