Update on Regulatory Submission for Aducanumab in Canada
Toronto, Ontario, June 9, 2022 – Biogen Canada Inc. has withdrawn its New Drug Submission (NDS) for aducanumab from regulatory review with Health Canada. Aducanumab was submitted as a treatment for early stages of Alzheimer’s disease, and based on the review to date, the agency indicated that the data provided would not be sufficient to support a marketing authorization in Canada.
Biogen maintains its commitment to furthering Alzheimer’s disease research, a devastating condition with far-reaching impact on society and a vast unmet need. As such, patients enrolled in ongoing clinical trials with aducanumab will not be impacted by this decision to withdraw the NDS. Biogen stands by the safety and efficacy of aducanumab and will continue to provide important information on the benefit risk profile of aducanumab with ongoing research and data collection.
“Our mission is to pioneer treatments and transform lives. We will continue to work towards this goal by investing in research and development and collaborating with the patient and medical communities,” said Eric Tse, General Manager, Biogen Canada Inc. “I would like to extend my thanks to the medical experts and patient communities who have provided their support, and those who continue to be involved in research with aducanumab and working towards bringing new treatment options to people living with Alzheimer’s disease.”
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 developed 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.
Since 1998, Biogen Canada has been delivering life-changing medicines and services that support unmet treatment needs and the lives of Canadians affected by neurological conditions. As a company that founds its culture on principles of equity, diversity and inclusion, Biogen Canada is proud to have been named a Best Workplace™ in Healthcare, for Inclusion, Giving Back and Hybrid Work. To learn more, please visit www.biogen.ca.
+1 416 234 7901