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The US Food and Drug Administration (FDA) grants expedited approval to Biogen to market its Alzheimer’s drug in the US. The drug in question is Aducanumab, also known as Aduhelm, which is the first Alzheimer’s drug approved since 2003.
Biogen’s drug for Alzheimer’s is a breakthrough in medicine
The US Food and Drug Administration (FDA) approved the drug Aducanumab for Alzheimer’s on 7 June 2021. Biogen licensed Aduhelm from Neurimmune in 2007 under a collaborative development and license agreement. Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of ADUHELM globally.
Aducanumab is a drug that slows down a disease that causes memory problems, among other things. The accelerated approval was granted based on clinical trial data showing Aduhelm’s effect on reducing amyloid beta plaques, a biomarker that is expected to have significant benefits, specifically reducing clinical deterioration. In clinical trials, Aduhelm reduced the number of amyloid beta plaques by, depending on the study, 59-71% after 18 months of treatment.
As the FDA stated in its announcement, under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.
Biogen is a company founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. The company has a portfolio of drugs for the treatment of multiple sclerosis, the company introduced the first approved treatment for spinal muscular atrophy, commercialising biosimilars to advanced biological drugs, and focuses on developing research programs in multiple sclerosis and neuroimmunology.