CAMBRIDGE, Mass., March 11, 2022 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced that the company will present new research on Alzheimer’s disease, as well as data for ADUHELM® (aducanumab-avwa) injection 100 mg/mL for intravenous use, at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022), to be held March 15-20 in Barcelona, Spain and virtually. These data include analyzes of the effect of treatment on biomarkers of Alzheimer’s disease in long-term extension studies, with more than two years of phase 3 data.
An invited plenary lecture, “Key Milestones in Alzheimer’s Disease” on March 16, will include a review of the ability of ADUHELM to reduce beta amyloid plaque and plasma p-tau181, and the relationship between these biomarkers and long-term clinical endpoints. term extension phase of the ADUHELM clinical program.
An oral presentation on March 18, “Effect of Reduced Brain β-Amyloid Levels on Cognitive Decline in Randomized Clinical Trials: An Updated Instrumental Variable Meta-Analysis,” will discuss details of a meta- analysis on causality between reduction of amyloid beta levels and reduction of cognitive decline in randomized clinical trials.
Main stages of Alzheimer’s disease [Budd Haeberlein S; 0290 – Plenary Lecture 3; PL003 / #12, Room: 115-117] – Wednesday March 16, 12:30 p.m. – 1:00 p.m. CET; 7:30 a.m. – 8:00 a.m. EDT
Phase 3 Studies of Aducanumab: Exposure-Response Analysis Assessing the Relationship Between Amyloid Clearance and Slowing Clinical Decline on CDR-SB Scores [Kandadi Muralidharan K, et al.; P225 / #1868, Virtual Poster Presentation] – Tuesday, March 15, from 8:00 a.m. CET; 3:00 a.m. EDT
Archived versions of the presentations will be available concurrently on the investor section of Biogen’s website at investor.biogen.com.
About ADUHELM® (aducanumab-avwa) injection 100 mg/mL for intravenous use
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 the disease, the population in which treatment was initiated in clinical trials. There are no safety or efficacy data on initiating treatment at earlier or more advanced stages of the disease than those studied. This indication is approved under an accelerated approval based on the reduction of beta-amyloid plaques observed 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 amyloid beta. Accumulation of beta-amyloid plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. Accelerated approval of ADUHELM was granted based on clinical trial data showing the effect of ADUHELM in reducing beta-amyloid plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in occurrence a reduction in clinical decline.
ADUHELM can cause serious side effects including: Abnormal Amyloid Imaging or “ARIA”. ARIA is a common side effect that usually causes no symptoms but 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 health care provider will perform magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for the presence of 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 healthcare provider for medical advice about side effects.
Since October 2017, Biogen and Eisai Co., Ltd. are collaborating in the global co-development and co-promotion of aducanumab.
Please click here for full prescribing information, including medication guide, for ADUHELM.
As pioneers in neuroscience, Biogen discovers, develops and delivers innovative therapies worldwide for people with serious neurological diseases and associated therapeutic adjacencies. One of the world’s first biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray and Nobel Laureates Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of drugs to treat multiple sclerosis, introduced the first approved therapy for spinal muscular atrophy, and provides the first and only approved therapy to treat a defining disease-defining pathology. Alzheimers. Biogen also commercializes biosimilars and is focused on advancing the industry’s most diverse neuroscience pipeline 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 in all company operations, establish collaborations with renowned institutions to advance science to improve human health outcomes and support underserved communities. served.
The Company periodically posts information that may be important to investors on its website at www.biogen.com. To learn more, visit www.biogen.com and follow Biogen on social media – Twitter, LinkedIn, Facebook, YouTube.
Biogen Safe Harbor
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, regarding the potential clinical effects of ADUHELM; the potential benefits, safety and efficacy of ADUHELM; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaborative arrangements with Eisai; clinical development programs, clinical trials, and data readouts and presentations; and the risks and uncertainties associated with drug development and commercialization. These statements can be identified by words such as “aim”, “anticipate”, “believe”, “could”, “estimate”, “expect”, “plan”, “intend”, ” may”, “plan”, “possible”, “potential”, “will”, “would”, and other words and terms of similar meaning. The development and commercialization of drugs involves a high degree of risk, and only a small number of research and development programs lead to commercialization of a product Results of early-stage clinical trials may not be indicative of full results or results of later-stage or larger clinical trials scale and do not guarantee regulatory approval.You should not place undue reliance on any such statements or any scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in these 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 unforeseen costs or delays; the risk of other unexpected obstacles; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties related to intellectual property claims and disputes; risks associated with current and potential future health care reforms; product liability claims; the risks of collaboration with third parties; 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, factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement together with the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports 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 undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.