Biogen Provides Regulatory Update on the Supplemental Biologic License Application (sBLA) for Subcutaneous Administration of ...
April 28 2021 - 6:20PM
Biogen Provides Regulatory Update on the Supplemental Biologic
License Application (sBLA) for Subcutaneous Administration of
TYSABRI® (natalizumab)
Biogen Inc. (Nasdaq: BIIB) today announced that it has received a
Complete Response Letter (CRL) from the U.S. Food and Drug
Administration (FDA) for its supplemental Biologic License
Application (sBLA) for a new subcutaneous (SC) route of
administration of TYSABRI® (natalizumab) to treat relapsing
multiple sclerosis (MS). The CRL indicates that the FDA is unable
to approve the Company’s filing as submitted. Biogen is evaluating
the CRL and will determine next steps in the U.S.
“We are committed to MS and pursuing innovations such as new
routes of administration to help provide options that could address
the individual needs of patients,” said Maha Radhakrishnan, M.D.,
Chief Medical Officer at Biogen. “This response from the FDA does
not affect the intravenous administration of TYSABRI, a
well-established high-efficacy treatment with a well-characterized
safety profile, which over the last 15 years has treated more than
200,000 people worldwide with relapsing MS.”
The subcutaneous delivery of TYSABRI was approved by the
European Commission in March 2021, and Biogen plans to pursue
regulatory filings in additional countries.
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 213,000 people worldwide have
been treated with TYSABRI, with over 835,000 patient-years of
experience, based on clinical trials and prescription data.1
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, other atypical 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 Twitter, LinkedIn, Facebook,
YouTube.
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 potential regulatory discussions,
submissions and approvals and the timing thereof; the potential
benefits, safety and efficacy of TYSABRI; the results of certain
real-world data; 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. 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 actual timing and
content of submissions to and decisions made by the regulatory
authorities; regulatory submissions may take longer or be more
difficult to complete than expected; regulatory authorities may
require additional information or further studies, or may fail or
refuse to approve or may delay approval of our drug candidates or
expansion of product labeling; failure to obtain regulatory
approvals in other jurisdictions; 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; 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:
- Combined post-marketing data based
on prescriptions and clinical trials exposure to TYSABRI as of
January 31, 2021.
MEDIA CONTACT:David Caouette+ 1 617 679
4945public.affairs@biogen.com |
|
INVESTOR CONTACT:Mike Hencke+1 781 464 2442IR@biogen.com
|
|
|
|
Biogen (TG:IDP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Biogen (TG:IDP)
Historical Stock Chart
From Jul 2023 to Jul 2024