Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 36 |
| INN | Aducanumab |
| Status | Approved |
| Drug code(s) | BIIB037, NI-101 |
| Brand name | Aduhelm |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Human B cell-derived |
| Target(s) | Amyloid beta |
| Indications of clinical studies | Alzheimer's Disease |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Approved US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2011 |
| Start of Phase 2 | |
| Start of Phase 3 | June 15, 2015 |
| Date BLA/NDA submitted to FDA | February 20, 2020 |
| Year of first approval (global) | 2021 |
| Date of first US approval | June 07, 2021 |
| INN, US product name | Aducanumab, aducanumab-avwa |
| US or EU approved indications | 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. |
| Company | Neurimmune |
| Licensee/Partner | Biogen |
| Comments about company or candidate | Jan 31, 2024: Biogen will discontinue the development and commercialization of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use and will terminate the ENVISION clinical study. This decision is not related to any safety or efficacy concerns. A large portion of the resources released resulting from termination of the ADUHELM program will be redeployed in Biogen’s AD franchise. In January 2023, Biogen began a strategic review of its research and development efforts, including seeking potential partners or external financing for ADUHELM, as part of a focus on prioritizing the company’s portfolio. During this process, Biogen considered the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval. Despite an extensive process, the company did not identify potential strategic partners or external financing. Biogen has recorded a one-time charge of approximately $60 million related to close out costs for the program in the fourth quarter of 2023. Biogen licensed aducanumab from Neurimmune and has terminated that license. The rights to aducanumab will revert to Neurimmune. April 2022: Biogen Inc. 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 Committee for Medicinal Products for Human Use (CHMP) indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of aducanumab by EMA. Biogen’s MAA had been under review by the CHMP in response to the company’s request for a re-examination of the negative opinion the regulatory body issued in December 2021. On December 17, 2021, Biogen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion on the Marketing Authorization Application for aducanumab. New Drug Application (NDA) was submitted in Japan in December 2020. It was disclosed in April 2021 that submission of MAA has been conducted in Brazil, Canada, Australia and Switzerland. In Canada, Australia and Switzerland, the validation of whether the applications are accepted is underway. Oct 21, 2020: Eisai Co., Ltd. announced that Biogen has disclosed its submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the review of aducanumab, an investigational treatment for Alzheimer’s disease, as of October 2020 in its Q3 2020 Earnings Press Release issued on October 21. This MAA is subject to validation of whether the EMA accepts the application for review, which Biogen plans to announce when notified. Source: eisai.com/news/2020/pdf/enews202065pdf.pdf Aug 2020: BLA receives priority review July 8 2020 press release: BLA submission complete April 2020: Biogen's Q1 update indicates that they started submitting modules for a BLA and expect to complete the submission in Q3 2020. • February 20, 2020 – The applicant opened BLA 761178 and submitted nonclinical information; BLA submission completed July 7, 2020. [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761178Orig1s000MedR_Redacted.pdf] October 2019: Biogen and Eisai, Co., Ltd. announced that, after consulting with the U.S. Food and Drug Administration (FDA), Biogen plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer’s disease (AD). The Phase 3 EMERGE Study met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients in the Phase 3 ENGAGE Study who received sufficient exposure to high dose aducanumab support the findings from EMERGE. After reviewing the data in consultation with the FDA, Biogen believes that the difference between the results of the new analysis of the larger dataset and the outcome predicted by the futility analysis was largely due to patients’ greater exposure to high dose aducanumab. March 2019: Biogen and Eisai announced they would terminate the Phase 3 ENGAGE and EMERGE trials of aducanumab for early Alzheimer’s disease. A futility analysis run by an independent data-monitoring committee concluded that that trials would not reach their primary endpoint, the slowing of cognitive decline as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB) In July 2018 Biogen completed enrollment in ENGAGE and EMERGE, the Phase 3 studies of aducanumab, Biogen’s anti-amyloid beta antibody candidate for early Alzheimer’s disease. Fast track designation granted in Aug 2016; EMA's PRIME designation granted June 2016. Two Phase 3 studies in early Alzheimer's disease started in mid-2015. IND 106230 for aducanumab (previously BIIB037) was opened in the United States on April 6, 2011. Biogen licensed the worldwide rights to aducanumab from Neurimmune in 2007. |
| Full address of company | 8952 Schlieren / Zurich Switzerland Europe Switzerland https://www.neurimmune.com/ |
ProMIS Neurosciences, Inc., a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, released a white paper that offers its perspective on aducanumab’s likelihood of regulatory approval in advance of its U.S. Food and Drug Administration Advisory Committee (AC) review on November 6, 2020. Source: https://promisneurosciences.com/news/promis-neurosciences-perspective-on-aducanumab-advancement-is-approval-likely/
| Anticipated events | Withdrawal soon? |
| Factor(s) contributing to discontinuation | None |