The European Commission Grants Marketing Authorization for New
Subcutaneous Administration of TYSABRI® (natalizumab) to Treat
Relapsing-Remitting Multiple Sclerosis
Biogen Inc. (Nasdaq: BIIB) today announced that the European
Commission (EC) has granted marketing authorization for a
subcutaneous (SC) injection of TYSABRI® (natalizumab) to treat
relapsing-remitting multiple sclerosis (MS). The new route of
administration offers comparable efficacy and safety to the TYSABRI
intravenous (IV) formulation building on the therapy’s long-term
data, established clinical benefits and well-characterized safety
profile. TYSABRI is the only high-efficacy MS therapy to offer two
routes of administration options providing patients and physicians
the flexibility to choose the one that best fits their individual
needs.
The SC and IV formulations of TYSABRI are dosed 300 mg, every
four weeks (Q4W) by a healthcare provider. The SC option expands
the clinical settings, beyond infusion centers, where patients can
be treated. In addition, the SC formulation is administered in a
shorter timeframe compared to the IV formulation and allows
physicians to reduce or remove the post-dose observation period for
some patients after six doses as clinically appropriate. The
addition of the SC administration also offers people living with MS
another option at a time when they are being encouraged to discuss
considerations around COVID-19 vaccination and their MS treatment
with their physicians.1,2
“The subcutaneous administration of TYSABRI expands choices when
it comes to controlling MS disease activity,” said Sven G. Meuth,
M.D., PhD, professor of Neurology and Director of the Clinic of
Neurology at the University Hospital of Düsseldorf. “I believe the
SC administration offers an opportunity to receive comparable
efficacy and safety to the intravenous formulation with reduced
administration time which may be meaningful for patients. For
physicians, the SC administration offers the ability to prescribe
and administer TYSABRI in their practice, providing more locations
where patients can be treated.”
The EC’s approval of the SC route of administration for TYSABRI
is based on data from the DELIVER and REFINE studies, which showed
comparability to the Q4W IV administration of 300mg TYSABRI in
efficacy, pharmacokinetic and pharmacodynamic profiles. Overall,
the safety of TYSABRI SC in both studies was generally consistent
with the well-established benefit-risk profile of TYSABRI IV in
other clinical studies and the post-marketing setting, with the
exception of injection site pain which can occur with SC
injections.3,4 “TYSABRI is a trusted high-efficacy
therapy with a well characterized safety profile for patients
living with MS. Nearly 15 years of real-world experience helps
reinforce its effectiveness in reducing MS disease activity,
showing that early treatment leads to better clinical outcomes,”
said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen.
“With chronic conditions like MS, we must continue to pursue
innovations that can help patients better integrate their treatment
preferences into their lives. This approval reflects our commitment
to explore new possibilities with TYSABRI and meet the evolving
needs of people living with MS.”
Approved by the EC in 2006, TYSABRI’s efficacy and safety have
been shown through clinical trials and extensive real-world
evidence gathered over nearly 15 years. During that time, Biogen
has initiated research, through efforts such as the MS PATHS
network and TYSABRI Observational program (TOP), that have
broadened the clinical data for TYSABRI providing physicians and
patients with more information on this established high-efficacy MS
therapy with a well-characterized safety profile.
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 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. In the U.S., TYSABRI is indicated as monotherapy for
the treatment of patients with relapsing forms of MS. TYSABRI is
approved in 80 countries, and approximately 213,000 people
worldwide have been treated with TYSABRI, with over 835,000
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-JC virus 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), a decrease in lymphocyte counts and
infections, including opportunistic and other atypical
infections.
For information on TYSABRI prescribing information in the EU,
please visit:
https://ec.europa.eu/health/documents/community-register/html/h346.htm.
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
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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 TYSABRI; the results of certain real-world data;
results from the DELIVER and REFINE studies; the identification and
treatment of MS; our research and development program for the
treatment of MS; and the potential of Biogen’s commercial business,
including TYSABRI. 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; 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; regulatory authorities may require
additional information or further studies, or may fail to approve
or may delay approval of our drug candidates or expansion of
product labeling; failure to obtain regulatory approvals in other
jurisdictions; 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
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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:
- National Multiple Sclerosis Society. COVID-19 Guidance for
People Living with MS. Available
at: https://www.nationalmssociety.org/coronavirus-covid-19-information/multiple-sclerosis-and-coronavirus/covid-19-vaccine-guidance.
Accessed: January 2021.
- Multiple Sclerosis International Federation. MS, the
coronavirus and vaccines – updated global advice. Available
at: https://www.msif.org/news/2020/02/10/the-coronavirus-and-ms-what-you-need-to-know/.
Accessed: January 2021.
- Plavina T, Fox EJ, Lucas N, et al. A Randomized trial
evaluating various administration routes of natalizumab in multiple
sclerosis. J Clin Pharmacol. 2016;56(10):1254-1262.
- Trojano M, Ramió-Torrentà L,
Grimaldi LM, et al. A randomized study of natalizumab dosing
regimens for relapsing–remitting multiple
sclerosis. Alternatives. April 2021:63-92. doi:
10.1177/03043754020270S105.
- Combined post-marketing data based
on prescriptions and clinical trials exposure to TYSABRI as of July
31, 2020.
MEDIA CONTACT:David Caouette+ 1
617 679 4945public.affairs@biogen.com |
INVESTOR CONTACT:Mike Hencke+1
781 464 2442IR@biogen.com |
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