Biogen
Statements

April 29, 2022
Biogen Statement Regarding Updated ADUHELM® (aducanumab-avwa) Prescribing Information in US

The US Food and Drug Administration (FDA) has approved an updated full Prescribing Information for ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use, which includes further guidance on how to monitor patients and provides additional safety information.

April 28, 2022
Biogen To Offer Continuity of Care Plan for U.S. Patients Currently Treated with ADUHELM® (aducanumab-avwa)

Biogen is announcing plans to help patients in the U.S. currently on ADUHELM avoid any treatment interruptions following the final national coverage determination by Centers for Medicare & Medicaid Services (CMS) that could result in a loss of coverage for Medicare beneficiaries. All U.S.

April 22, 2022
Update on Regulatory Submission for Aducanumab in the European Union

Biogen Inc. (Nasdaq: BIIB) has notified the European Medicines Agency (EMA) of its decision to withdraw its Marketing Authorization Application (MAA) for aducanumab for the treatment of the early stages of Alzheimer’s disease. The company withdrew its application following interactions with EMA’s

April 7, 2022
Biogen’s Statement on the Final National Coverage Determination for Amyloid-Beta Targeting Therapies for the Treatment of Alzheimer’s Disease

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class.

March 18, 2022
The National Minority Quality Forum and Biogen Highlight Equitable Access to Research and Care in Real World Evidence White Paper

The National Minority Quality Forum (NMQF) and Biogen will today discuss the importance of generating real-world evidence on a webinar hosted by NMQF on equitable access to research and care. Together, the organizations have also issued a white paper highlighting how real-world evidence (RWE) is

February 10, 2022
Biogen Submits Response to the Centers for Medicare and Medicaid Services (CMS) Proposed National Coverage Determination (NCD) for Anti-Amyloid Treatments in Alzheimer’s Disease

Biogen Response to CMS

January 11, 2022
Biogen’s Statement on the Draft National Coverage Determination (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

Alzheimer’s patients and their families deserve to have choice and access to FDA-approved treatments. Biogen believes that the proposed coverage with evidence development (CED) decision for anti-amyloid therapies denies nearly all Medicare beneficiaries from accessing ADUHELM® (aducanumab-avwa) 100

November 22, 2021
Statement on JAMA Neurology Publication about Amyloid-Related Imaging Abnormalities in Two Phase 3 Studies Evaluating Aducanumab in Early Alzheimer’s Disease

Today, Biogen and Eisai announced that the Journal of the American Medical Association (JAMA) Neurology published a peer-reviewed paper about findings around amyloid-related imaging abnormalities (ARIA) in the Phase 3 trials of ADUHELM (aducanumab-avwa).

November 2, 2021
A Letter from Alphonse Galdes, Ph.D., Head of Pharmaceutical Operations and Technology at Biogen: It’s Time for Companies to Act Like the Climate Crisis is a Health Crisis

Right now, delegations are descending upon Glasgow for the 26th annual United Nations Climate Change Conference (COP26) – with more than 100 world leaders gathering to accelerate climate action to meet goals set by the Paris Agreement and the UN Framework Convention on Climate Change.

September 23, 2021
Biogen Issues First Progress Report of its Signature Healthy Climate, Healthy Lives™ Initiative

September 23, 2021  – In 2020, Biogen launched its signature Healthy Climate, Healthy Lives™ initiative, a groundbreaking $250 million, 20-year commitment to address the deeply interrelated issues of climate, health, and equity. Biogen is the first Fortune 500 company to commit to becoming fossil