Update on the Phase 4 Confirmatory Study of ADUHELM®
Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. announce progress on the Phase 4 post-marketing confirmatory study of ADUHELM (aducanumab-avwa) for Alzheimer’s disease. The final protocol will be submitted to the FDA by March 2022, followed by patient screening in May 2022. The global, placebo-controlled trial aims to enroll over 1,300 patients with an expected primary completion in four years. This study is a requirement of the FDA's accelerated approval for ADUHELM, which targets amyloid beta plaques in Alzheimer’s patients.
- Anticipated submission of the final study protocol to the FDA by March 2022.
- Aim to start patient screening by May 2022, indicating progress in the study timeline.
- Commitment to complete the confirmatory study in four years, potentially ahead of FDA expectations.
- No significant negative aspects reported.
CAMBRIDGE, Mass., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today provided an important update on the continuing progress of the Phase 4 post-marketing confirmatory study of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use in Alzheimer’s disease.
The companies anticipate submitting the final protocol for review to the U.S. Food and Drug Administration (FDA) in March 2022, with the initiation of patient screening in May 2022. The study is a post-marketing requirement of the FDA’s accelerated approval and will be a global, placebo-controlled trial, aiming to enroll more than 1,300 early Alzheimer’s disease patients, with a primary clinical endpoint at 18 months after treatment initiation. Based on enrollment rates from the previous Phase 3 trials with ADUHELM, the primary completion date is expected to be approximately four years after the study begins. The trial will also include a long-term extension to collect longer-term treatment data for up to 48 months.
“We are delivering on our commitment to accelerate the timelines with the goal to complete the confirmatory study well ahead of schedule,” said Priya Singhal M.D., M.P.H., Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen. “Together with EMBARK, Biogen’s redosing study, and the ICARE AD study, we aim to provide data from real-world practice and clinical trials to further inform patient and physician decisions about treatment.”
“I am very encouraged by this update and Biogen’s and Eisai’s goal to complete the trial in four years after its initiation, approximately half of the time that the FDA provided as part of the accelerated approval,” said Marwan Sabbagh, M.D., FAAN, Professor of Neurology, Alzheimer's and Memory Disorders Division, Barrow Neurological Institute. “This is a significant commitment from the companies. It takes time to execute a complex, global trial of this nature, so I am pleased to see the high level of priority being afforded to this study.”
The companies will continue to work with FDA, external stakeholders and regulators in other geographies on the study design.
About ADUHELM® (aducanumab-avwa) injection 100 mg/mL solution for intravenous use
In the United States, 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).
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 in the United States 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.
As of October 2017, Biogen and Eisai Co., Ltd. are collaborating on the global co-development and co-promotion of aducanumab.
Please click here for U.S. 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 the 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,
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About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai’s corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
Leveraging the experience gained from the development and marketing of a treatment for Alzheimer’s disease, Eisai aims to establish the “Eisai Dementia Platform.” Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a “Dementia Ecosystem,” by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.
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, about potential regulatory discussions, submissions and approvals and the timing thereof, the potential clinical effects of ADUHELM; the potential benefits, safety and efficacy of ADUHELM; Biogen’s strategy and plans; potential of, and expectations for, Biogen’s commercial business and pipeline programs, including ADUHELM and the post-marketing required study; planning and timing for the commercial launch of, and access to, ADUHELM; anticipated manufacturing, distribution, and supply of ADUHELM; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including ADUHELM; 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, uncertainty of success in the development and commercialization of ADUHELM; risks relating to the launch of ADUHELM, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for ADUHELM, and other unexpected difficulties or hurdles; unexpected concerns that may arise from additional data or analysis obtained during clinical trials; the occurrence of adverse safety events, restrictions on use, or product liability claims; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, including ADUHELM; risks of unexpected costs or delays; the risk of other unexpected hurdles; risks relating to investment in our manufacturing capacity; problems with our manufacturing processes; 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; risks associated with current and potential future healthcare reforms; risks relating to the distribution and sale by third parties of counterfeit or unfit versions of our products; 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 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.
| MEDIA CONTACTS: Biogen Ashleigh Koss + 1 908 205 2572 public.affairs@biogen.com Eisai Inc. (U.S. Media) Public Relations Department TEL : 1 201 753 1945 Eisai Co., Ltd. (Media Outside the U.S.) Public Relations Department TEL : +81 (0)3 3817 5120 | INVESTOR CONTACTS: Biogen Mike Hencke +1 781 464 2442 IR@biogen.com Eisai Co., Ltd. Investor Relations Department TEL: +81-(0)70-8688-9685] |
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