Biogen Submits Final Protocol for ADUHELM® (aducanumab-avwa) Phase
4 ENVISION Trial to FDA
Biogen Inc. (Nasdaq: BIIB) has submitted the final study
protocol for the confirmatory Phase 4 ENVISION trial to the U.S.
Food and Drug Administration (FDA) for review and approval. This is
in line with the company’s commitment to accelerate the timelines
for the trial, including submitting the final study protocol to the
FDA in March 2022, as previously announced. Biogen expects the
first patient to enter screening in May 2022 and the trial’s
primary completion approximately four years after the study begins.
The confirmatory ENVISION trial is a requirement based on FDA’s
accelerated approval of ADUHELM® (aducanumab-avwa) 100 mg/mL
injection for intravenous use in early Alzheimer’s disease (Mild
Cognitive Impairment due to Alzheimer’s disease and mild
Alzheimer’s disease).
The study, as previously announced, will be a global,
placebo-controlled trial, aiming to enroll around 1,500 patients
with early Alzheimer’s disease and confirmation of amyloid beta
pathology.
The company has also reaffirmed the trial’s goal of recruiting
at least 18 percent of patients in the U.S. from Black/African
American and Latino communities.
“Our unwavering commitment is to ensure that the trial is
completed swiftly and that the diversity of patients in it reflects
that of Americans diagnosed with early Alzheimer’s disease,” said
Samantha Budd Haeberlein, Ph.D., SVP, Head of Neurodegeneration
Development at Biogen. “We plan to work hand-in-hand with
underrepresented communities and Alzheimer’s disease groups to
achieve our diversity and inclusion goal.”
To increase participation among historically underrepresented
patients, Biogen is leveraging multiple initiatives and working
with several community groups, such as the National Minority
Quality Forum and others who have expertise and a commitment in
helping to overcome traditional enrollment barriers for diverse
populations. These efforts are being addressed by three key
strategies:
- Selecting sites with diverse staff,
located in communities of color, with access to diverse patient
populations;
- Supporting trial sites in
identification, outreach, and engagement of underrepresented
communities; and
- Engaging with community and patient
organizations to increase Alzheimer’s disease awareness, education,
and access to research.
The primary endpoint for the trial will be measured by the
Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months, as
announced in January 2022. The trial will also include a planned
long-term extension to collect treatment data for up to 48
months.
Secondary endpoints include changes in Amyloid Positron Emission
Tomography (PET) and Tau PET, as well as the Alzheimer's Disease
Assessment Scale-Cognitive Subscale (ADAS-Cog 13), Alzheimer's
Disease Cooperative Study - Activities of Daily Living Inventory -
Mild Cognitive Impairment Version (ADCS-ADL-MCI), Integrated
Alzheimer's Disease Rating Scale (iADRS), Mini-Mental State
Examination (MMSE) and Neuropsychiatric Inventory (NPI-10).
About
ADUHELM® (aducanumab-avwa)
injection 100 mg/mL for intravenous useADUHELM 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).
ADUHELM is a monoclonal antibody directed against amyloid beta.
The accumulation of amyloid beta plaques in the brain is a defining
pathophysiological feature of Alzheimer’s disease. 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 clinical decline.
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.
Although most people 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. ADUHELM can also cause serious allergic
reactions. The most common side effects of ADUHELM include:
swelling in areas of the brain, with or without small spots of
bleeding in the brain or on the surface of the brain (ARIA);
headache; and fall. Patients should call their healthcare provider
for medical advice about side effects.
From 2017 to March 13, 2022, Biogen and Eisai jointly
collaborated on the development, commercialization and
manufacturing of ADUHELM. Effective March 14, 2022, Biogen has sole
decision-making authority over the development, commercialization
and manufacturing of ADUHELM. In 2022 the parties will continue in
a global profit/loss sharing arrangement subject to a cap on
Eisai’s expenses for 2022. Eisai will be entitled to a tiered
royalty on net sales of ADUHELM as of January 1, 2023.
Please click here for full Prescribing Information,
including Medication Guide, for ADUHELM.
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and
delivers worldwide innovative therapies for people living with
serious neurological 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, Sir Kenneth Murray, and Nobel Prize winners Walter
Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of
medicines to treat multiple sclerosis, has introduced the first
approved treatment for spinal muscular atrophy, and is providing
the first and only approved treatment to address a defining
pathology of Alzheimer’s disease. Biogen is also commercializing
biosimilars and focusing on advancing the industry’s most
diversified pipeline in neuroscience that will transform the
standard of care for patients in several areas of high unmet
need. In 2020, Biogen launched a bold 20-year, $250 million
initiative to address the deeply interrelated issues of climate,
health, and equity. Healthy Climate, Healthy Lives™ aims to
eliminate fossil fuels across the company’s operations, build
collaborations with renowned institutions to advance the science to
improve human health outcomes, and support underserved
communities. The company routinely posts information that may
be important to investors on our website at www.biogen.com. To
learn more, please visit www.biogen.com and follow Biogen
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 the potential clinical effects of
ADUHELM; the potential benefits, safety and efficacy of ADUHELM;
the treatment of Alzheimer’s disease; clinical development
programs, clinical trials and data readouts and presentations; and
risks and uncertainties associated with drug development and
commercialization. These statements may be identified by words such
as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “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 unexpected concerns
that may arise from additional data, analysis or results obtained
during clinical trials; the occurrence of adverse safety events;
risks of unexpected costs or delays; the risk of other unexpected
hurdles; failure to protect and enforce Biogen’s data, intellectual
property and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; risks associated with
current and potential future healthcare reforms; product liability
claims; third party collaboration risks; and the direct and
indirect impacts of the ongoing COVID-19 pandemic on Biogen’s
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 Biogen’s expectations in any
forward-looking statement. Investors should consider this
cautionary statement as well as the risk factors identified in
Biogen’s most recent annual or quarterly report and 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.
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CONTACT(S):BiogenAshleigh Koss+ 1 908 205
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