Biogen Inc. (Nasdaq: BIIB) today announced results from the
two-year prospective, randomized, interventional, controlled,
open-label Phase 3b NOVA study (NCT03689972). NOVA was designed to
estimate a potential difference between the efficacy of every
six-week (Q6W) 300mg natalizumab intravenous (IV) administration
compared to the efficacy of the approved every four-week (Q4W) dose
in people treated with TYSABRI® (natalizumab) (n=499) for
relapsing-remitting multiple sclerosis (MS) after at least one year
of disease stability on a Q4W IV dosing schedule.
The primary endpoint showed a numerical difference between the
mean number of new or newly enlarging T2 hyperintense lesions at
week 72 of 0.05 (Q4W) and 0.20 (Q6W) (p=0.0755), which based on the
full trial results is not clinically meaningful. The numerical
difference was driven by a high number of lesions occurring in two
participants in the Q6W arm – one patient who developed lesions
three months after treatment discontinuation and a second patient
who developed asymptomatic progressive multifocal
leukoencephalopathy (PML), a rare but serious brain infection. The
proportion of patients that developed new or newly enlarging T2
lesions in each arm was 4.1 percent (Q4W) and 4.3 percent
(Q6W).
There were no statistically significant or clinically meaningful
differences in secondary endpoints at week 72 between the Q4W and
Q6W treatment arms, and disease activity was well-controlled
in both arms:
- Annualized relapse rates were low
at 0.00010 (Q4W) and 0.00013 (Q6W), with 97.9 percent patients in
the Q4W arm remaining relapse-free compared to 97.2 percent of
patients in the Q6W arm.
- The proportion of patients that
developed T1 hypointense lesions in each arm was 1.1 percent (Q4W)
and 1.4 percent (Q6W).
- Both arms demonstrated 0.5 percent
of participants with gadolinium (Gd) enhancing T1 lesions.
“The NOVA study provides the first prospective, randomized
efficacy data of every six-week dosing with natalizumab, building
on its well-established clinical profile and the real-world
findings1,2,3,” said Maha Radhakrishnan, M.D., Chief Medical
Officer at Biogen. “In addition to the safety analyses from the
TOUCH Prescribing Program, which showed significant reduction in
the probability of PML, the results from NOVA deliver a more
comprehensive understanding of the six-week dosing regimen of
natalizumab.”
The NOVA study was initiated 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.
An updated analysis of data from TOUCH showed that an average Q6W
dosing regimen is associated with an 88 percent reduction (hazard
ratio 0.118, p<0.0001) in the probability of PML in comparison
to the approved Q4W dose.4
The safety findings in the NOVA study were consistent with the
known safety profile of IV natalizumab and the incidence of adverse
events and serious adverse events were similar between the two
treatment arms. One patient with asymptomatic PML in the Q6W arm
was high-risk based on the known risk factors (anti-JCV antibody
index >1.5, and >2 years of TYSABRI treatment), underlying
the importance of PML monitoring and risk factor
considerations in patients treated with natalizumab.
A complete analysis of the study data is ongoing and detailed
results will be shared in a future scientific forum. Natalizumab is
available commercially under the brand name TYSABRI and the only
approved dose is 300mg on a Q4W regimen.
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 220,000 people worldwide have
been treated with TYSABRI, with over 880,000 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 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) and Q6W; the results of the NOVA
Phase 3b 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. 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; 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 January 31, 2021.
MEDIA CONTACT:Allison Parks+ 1
781 464 3260public.affairs@biogen.com |
INVESTOR CONTACT:Mike Hencke+1
781 464 2442IR@biogen.com |
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