Biogen Inc. (Nasdaq: BIIB) - On June 7, 2021, ADUHELM became the
first approved treatment to address a defining pathology of
Alzheimer’s disease: targeting the reduction of amyloid plaques in
the brain. We believe patients, family members and physicians
deserve the facts about the therapy and the process by which it was
approved so they may make informed decisions.
The approval of ADUHELM by the U.S. Food and Drug Administration
(FDA) came after an extensive development, testing and review
process. Over more than a decade, we at Biogen engaged in rigorous
and science-driven research and development that assessed whether
ADUHELM could help patients worldwide who suffer from Alzheimer’s
disease. We are proud of the work our dedicated team has done to
develop ADUHELM, and of the potential it brings to Alzheimer’s
patients. We are equally proud of the professionalism both our team
and the FDA demonstrated during a thorough review process.
Unfortunately, ADUHELM’s approval has been the subject of
extensive misinformation and misunderstanding. It is normal for
scientists and clinicians to discuss data from experiments and
clinical trials, to debate, and to disagree, on the interpretation
of data. That is how science advances and we welcome these
discussions. Recently, however, there has been a turn outside the
boundaries of legitimate scientific deliberation.
We welcome a formal review into the interactions between the FDA
and Biogen on the path to the approval of aducanumab. A better
understanding of the facts is good for everyone involved to assure
confidence in both the therapy and the process by which it was
approved as we prioritize the issues that affect patients.
A step toward such transparency is to correct some of the
misinformation we have seen:
More than 250 drugs have been granted Accelerated
Approval by the FDA.
The FDA instituted its Accelerated Approval Program in 1992 to
allow for earlier approval of drugs that treat serious conditions,
and to fill an unmet medical need based on a surrogate endpoint
that is reasonably likely to predict a clinical outcome. Since
1992, 253 accelerated approvals have been granted to drugs to treat
HIV/AIDS, sickle cell anemia, Duchenne muscular dystrophy (DMD),
multiple sclerosis (MS) and particularly in the oncology
therapeutic area. In oncology, for example, the surrogate may be
tumor shrinkage, as this is likely to predict increased survival.
Many cancer patients have benefitted from novel immunotherapy
treatments that have received accelerated approval, and death rates
from cancer have declined dramatically.
The accelerated approval of ADUHELM has been granted based on
data from clinical trials showing the effect of ADUHELM on reducing
amyloid beta plaques, a surrogate biomarker that is reasonably
likely to predict clinical benefit, in this case a reduction in the
rate of clinical decline. We believe that this will be further
established as we collect more data from the ongoing EMBARK study
and the post-marketing confirmatory trial.
Several people have stated that all previously studied
anti-amyloid antibodies clear amyloid from the brain but have
failed as a class to demonstrate benefit. This is factually
incorrect. First generation anti-amyloid antibodies were not
specific for aggregated forms of amyloid beta, or targeted soluble
monomeric amyloid beta, or were deficient in effector function. As
a result, these antibodies do not clear amyloid from the brain. As
such, there is no basis for using the failure of these antibodies
as a reason to question the approval of ADUHELM.
The review process that led to accelerated approval was
extensive and thorough, during which we responded to numerous
questions and requests from the FDA. The approval is supported by
data of more than 3,000 patients and 2.2 million pages of clinical
data and analyses.
Separately, we have seen statements that all of ADUHELM’s
results are “post hoc” – in other words, that a filter was applied
after the fact to interpret the data in a certain way. That is also
factually incorrect. The primary and secondary endpoints had
been pre-specified in the Phase 3 trial protocols, before the first
patient was enrolled into the trials. The ADUHELM label shows
the results on these pre-specified endpoints, based on data that
had already been collected at the sites by the time the trials were
prematurely terminated on March 21, 2019. Safety data were also
extensively reviewed and are well documented in the label, so that
physicians can make informed benefit-risk decisions and take
appropriate actions as they monitor their patients under
treatment.
It is important to recognize that collaboration between industry
and regulatory agencies is common, appropriate and beneficial. That
was exemplified at its best with the COVID-19 vaccine development.
As a doctor, a scientist and the Head of Research and Development
at Biogen, I believe scientists at regulatory agencies and drug
manufacturers must work together in an effort to defeat other
devastating public health threats.
The FDA’s decision to approve ADUHELM to treat patients
with Alzheimer’s disease was based on thorough analysis of the
data.
As stated by Dr. Patrizia Cavazzoni, Director, the FDA Center
for Drug Evaluation and Research, in discussing the agency’s
decision to approve the treatment: “In all studies in which it was
evaluated… ADUHELM consistently and very convincingly reduced the
level of amyloid plaques in the brain in a dose- and time-dependent
fashion.” At the time of approval of ADUHELM, the FDA further
stated: “The clinical trials for ADUHELM were the first to show
that a reduction in these plaques—a hallmark finding in the brain
of patients with Alzheimer’s—is expected to lead to a reduction in
the clinical decline of this devastating form of dementia.”1
The FDA also stated: “Although the ADUHELM data are complicated
with respect to its clinical benefits, FDA has determined that
there is substantial evidence that ADUHELM reduces amyloid beta
plaques in the brain and that the reduction in these plaques is
reasonably likely to predict important benefits to patients.”1 The
FDA also shared that it “is requiring Biogen to conduct a
post-approval clinical trial to verify the drug’s clinical
benefit.”1
In the announcement of its decision to approve ADUHELM through
its Accelerated Approval pathway, the FDA explained the rigor
underlying its analysis: “We examined the clinical trial findings
with a fine-tooth comb, we solicited input from the Peripheral
and Central Nervous System Drugs Advisory Committee, we listened to
the perspectives of the patient community, and we reviewed all
relevant data. We ultimately decided to use the Accelerated
Approval pathway—a pathway intended to provide earlier access to
potentially valuable therapies for patients with serious diseases
where there is an unmet need, and where there is an expectation of
clinical benefit despite some residual uncertainty regarding that
benefit. In determining that the application met the requirements
for Accelerated Approval, the Agency concluded that the benefits of
ADUHELM for patients with Alzheimer’s disease outweighed the risks
of the therapy.”1
ADUHELM is the first Alzheimer’s treatment approved since 2003.
An important question is being overlooked by many: what would be
the impact of deferring access to this treatment, despite the
clinical data underlying its approval? Based on our current
estimates of the progression rates of the disease, every day over
1,000 Americans will advance from early stages of disease to
moderate and severe stages of disease, and thus may progress beyond
the stages during which ADUHELM should be initiated.2 We feel a
strong obligation to be able to offer new options to patients with
this devastating disease.
ADUHELM’s approval is paving the way for more innovation
and competition in Alzheimer’s disease.
The approval of ADUHELM has already renewed investment activity
in Alzheimer’s disease research and development, and we are
optimistic that other innovative treatments will soon join
ADUHELM.
This cycle of innovation is common in the biopharmaceutical
industry. It is how HIV/AIDS and many forms of cancer were changed
from untreatable diseases into conditions with viable treatment
options. MS is another good example. The first MS therapy,
introduced in 1993 via the first accelerated approval of a biologic
product, set in motion a cycle of innovation that resulted in now
more than 20 treatments approved, including six developed by
Biogen. These precedents contradict the claims by some who have
opined that the approval of ADUHELM would inhibit the development
of other drugs for Alzheimer’s disease.
We recognize that ADUHELM’s dataset was complex and its journey
to this point did not follow a conventional path. But the road to
innovation is rarely straightforward, and ADUHELM is not an
exception. Throughout, our team has worked with steadfast
determination to follow the science and be driven by an acute
understanding of the pain and suffering Alzheimer’s disease
inflicts on patients, families and society. We stand behind the
clinical evidence provided by the studies and the data-driven
scientific approach taken.
We will continue to put science first, be transparent with our
data and do all we can to assure that physicians have accurate and
complete information on which to base the important decisions
regarding their patients’ care.
INDICATION and IMPORTANT SAFETY INFORMATION
INDICATION ADUHELM is indicated for the
treatment of Alzheimer’s disease. Treatment with ADUHELM should be
initiated in patients with mild cognitive impairment or mild
dementia stage of disease, the population in which treatment was
initiated in clinical trials. There are no safety or effectiveness
data on initiating treatment at earlier or later stages of the
disease than were studied. This indication is approved under
accelerated approval based on reduction in amyloid beta plaques
observed in patients treated with ADUHELM. Continued approval for
this indication may be contingent upon verification of clinical
benefit in confirmatory trial(s).
IMPORTANT SAFETY INFORMATION What is
the most important information a patient should know about
ADUHELM? ADUHELM can cause serious side effects
including: Amyloid Related Imaging Abnormalities or
“ARIA”. ARIA is a common side effect that does not
usually cause any symptoms but can be serious. It is most
commonly seen as temporary swelling in areas of the brain that
usually resolves over time. Some people may also have small spots
of bleeding in or on the surface of the brain with the swelling.
Although most people with swelling in areas of the brain do not
have symptoms, some people may have symptoms such as: headache,
confusion, dizziness, vision changes, and nausea. The patient’s
healthcare provider will do magnetic resonance imaging (MRI) scans
before and during treatment with ADUHELM to check for ARIA.
Patients should call their healthcare provider or go to the
nearest hospital emergency room right away if they have any of the
symptoms listed above.
Before receiving ADUHELM, patients should tell their
healthcare provider about all of their medical conditions,
including if: they are pregnant or plan to become pregnant
or are breastfeeding or plan to breastfeed. It is not known if
ADUHELM will harm their unborn baby or if aducanumab-avwa (the
active ingredient in ADUHELM) passes into breast milk.
What are the possible side effects of ADUHELM? ADUHELM
can cause serious side effects, including: See above “What is the
most important information a patient should know about
ADUHELM?”
Serious allergic reactions. Swelling of the
face, lips, mouth, or tongue and hives have happened during an
ADUHELM infusion. Patients should tell their healthcare provider if
they have any of the symptoms of a serious allergic reaction during
or after an ADUHELM infusion.
The most common side effects of ADUHELM include: swelling in
areas of the brain, with or without small spots of bleeding in or
on the surface of the brain (ARIA); headache and fall. Patients
should call their healthcare provider for medical advice about side
effects. Patients may report side effects to FDA at
1-800-FDA-1088.
Please see full Prescribing
Information including Medication
Guide.
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 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:
Biogen’s strategy and plans; potential of, and expectations for,
Biogen’s commercial business, including ADUHELM; the potential
clinical effects of ADUHELM; the potential benefits, safety and
efficacy of ADUHELM; the identification and treatment of
Alzheimer’s disease; the anticipated benefits and potential of our
collaboration arrangements with Eisai; the clinical development
program and future clinical trial(s) for ADUHELM; and risks and
uncertainties associated with drug development and
commercialization. These forward-looking statements may be
accompanied by such words as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,”
“plan,” “potential,” “possible,” “prospect,” “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: 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, including ADUHELM; unexpected concerns that may arise
from additional data or analysis obtained during clinical trials;
actual timing and content of submissions to and decisions made by
the regulatory authorities regarding ADUHELM; the occurrence of
adverse safety events, restrictions on use or product liability
claims; risks of unexpected costs or delays; the risk of other
unexpected hurdles; failure to protect and enforce our data,
intellectual property and other proprietary rights and
uncertainties relating to intellectual property claims and
challenges; third party collaboration risks; the direct and
indirect impacts of the ongoing COVID-19 pandemic on our business,
results of operations and financial condition; and any other risks
and uncertainties that are described in other reports Biogen has
filed with the U.S. Securities and Exchange Commission. These
statements are based on Biogen’s current beliefs and expectations
and speak only as of the date of this news release. Biogen does not
undertake any obligation to publicly update any forward-looking
statements, whether as a result of new information, future
developments or otherwise.
1
https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease2
Biogen date on file
Contacts |
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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