The first Japanese committee on new drugs for the pharmaceutical industry



CAMBRIDGE, Mass., December 22, 2021 (GLOBE NEWSWIRE) – Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the first New Medicines Committee (NDC) of the Pharmaceutical Affairs and Food Hygiene Council which advises Japan’s Ministry of Health, Labor and Welfare (MHLW) has decided to continue deliberations on the application for authorization to manufacture and market aducanumab for the treatment of Alzheimer’s disease. The NDC is seeking to submit additional data as part of this process. The companies will continue to actively engage with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to agree on additional data requirements. Biogen and Eisai remain committed to rapidly providing aducanumab to patients in Japan.

About ADUHELM® (aducanumab-avwa) 100 mg / mL solution for injection 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, the population in which treatment was initiated in clinical trials. There are no safety or efficacy data on the initiation of treatment at earlier or later stages of the disease than those that have been studied. This indication is approved as part of an accelerated approval based on the reduction in beta-amyloid plaques seen in patients treated with ADUHELM. Continued approval for this indication may depend on verification of clinical benefit in the confirmatory trial (s).

ADUHELM is a monoclonal antibody directed against beta-amyloid. The build-up of beta-amyloid plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. The accelerated approval of ADUHELM was granted based on clinical trial data showing the effect of ADUHELM on the reduction of beta-amyloid plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in the occurrence a reduction in clinical decline.

ADUHELM can cause serious side effects, including: Imaging abnormalities related to amyloid or “ARIA”. ARIA is a common side effect that usually doesn’t cause any symptoms, but it can be serious. Although most people do not have symptoms, some people may experience symptoms such as: headache, confusion, dizziness, blurred vision, and nausea. The patient’s healthcare provider will perform 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 certain areas of the brain, with or without small bleeding spots in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their health care provider for medical advice on side effects.

As of October 2017, Biogen and Eisai Co., Ltd. collaborate in the global co-development and co-promotion of aducanumab.

Please click here to Complete prescribing information, including Medication Guide, for ADUHELM.

About Biogen
As a pioneer in neuroscience, Biogen discovers, develops and delivers innovative therapies worldwide for people living with severe neurological diseases and associated 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 drugs to treat multiple sclerosis, introduced the first approved treatment for spinal muscular atrophy, and provides the first and only treatment approved to treat a defining pathology of Alzheimer’s disease. Biogen also markets biosimilars and is focused on advancing the industry’s most diverse 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 deeply intertwined issues of climate, health and equity. Healthy Climate, Healthy Lives â„¢ aims to eliminate fossil fuels in all business operations, establish collaborations with renowned institutions to advance science to improve human health outcomes and support communities underserved.

The company regularly posts information that may be important to investors on its website at www.biogen.com. To learn more, please visit www.biogen.com and follow Biogen on social media – Twitter, LinkedIn, Facebook, YouTube.

About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai’s business philosophy is based on human healthcare (hhc), which involves thinking about patients and their families first, and increasing 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 unmet medical needs, with particular emphasis on our strategic areas of neurology and oncology.

Building on the experience gained during the development and commercialization of a treatment for Alzheimer’s disease, Eisai aims to establish the “Eisai Dementia Platform”. Through this platform, Eisai plans to deliver new benefits to people with dementia and their families by building a “dementia ecosystem”, collaborating with partners such as medical organizations, development companies, diagnostics, research organizations and bio-companies in addition to private companies. insurance agencies, financial industries, fitness clubs, auto manufacturers, retailers and healthcare facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.

Biogen Safety Zone
This press release contains forward-looking statements, including statements made in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, regarding and timing of potential regulatory discussions, submissions and approvals, the potential clinical effects of ADUHELM; the potential benefits, safety and efficacy of ADUHELM; Biogen’s strategy and plans; the potential and expectations of Biogen’s commercial and pipeline programs, including ADUHELM and the required post-market study; the planning and timing of the commercial launch and access to ADUHELM; the planned manufacture, distribution and supply of ADUHELM; the treatment of Alzheimer’s disease; the expected benefits and potential of Biogen’s collaborative arrangements with Eisai; the potential of Biogen’s business operations and pipeline programs, including ADUHELM; and the risks and uncertainties associated with the development and commercialization of drugs. These statements can be identified by words such as “aim”, “anticipate”, “believe”, “could”, “estimate”, “expect”, “foresee”, “intend”, “may “,” “Possible”, “potential”, “will”, “would” and other words and terms with similar meanings. Drug development and commercialization carries a high degree of risk, and only a small number of programs research and development results in the commercialization of a product. Results of early stage clinical trials may not be indicative of complete results or the results of later stage or larger scale clinical trials and do not guarantee 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, the uncertainty of success in the development and commercialization of ADUHELM; risks of launching ADUHELM, including the readiness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for ADUHELM, and other unexpected difficulties or obstacles; 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 studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, including ADUHELM; risks of unforeseen costs or delays; the risk of other unexpected obstacles; risks associated with investing 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 disputes; risks of collaboration with third parties; the risks associated with current and future health care reforms; risks associated with the distribution and sale by third parties of counterfeit or unsuitable 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 out many factors, but not all, 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 risk factors identified in Biogen’s most recent annual or quarterly report and other reports that Biogen has filed with the United States Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this press release. Biogen makes no commitment to publicly update any forward-looking statements, whether as a result of new information, future developments, or otherwise.

MEDIA CONTACT (S):
Biogenic
Ashleigh Koss
+ 1 908 205 2572
[email protected]
INVESTOR CONTACT (S):
Biogenic
Mike hencke
+1 781 464 2442
[email protected]
Eisai Co., Ltd. (Media outside the United States)
Public relations department
TEL: +81 (0) 3 3817 5120
Eisai Co., Ltd.
Investor Relations Department
TEL: + 81- (0) 70-8688-9685]


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