Biogen and Eisai are set to face a Food and Drug Administration (FDA) advisory committee on June 8 for a review of their jointly-developed Alzheimer’s drug, Aduhelm. The drug has been submitted for full approval, and the committees will review data from clinical trials.
The decision to bring Aduhelm to an FDA advisory committee was based on the recommendation of an independent panel of advisers who met in November and raised concerns about the strength of the data supporting Aduhelm’s approval. The panel recommended against approval, citing insufficient evidence of the drug’s effectiveness.
Aduhelm is designed to slow the progression of Alzheimer’s disease by reducing beta-amyloid plaque in the brain, which is believed to be a key factor in the development of the disease. The drug received “accelerated approval” from the FDA in June 2021 based on the drug’s ability to reduce beta-amyloid plaque. Aduhelm is the first drug authorized by the FDA for the treatment of Alzheimer’s disease in nearly two decades.
The FDA’s accelerated approval program allows for drugs to be approved based on a surrogate endpoint, such as a reduction in beta-amyloid plaque, rather than relying on direct evidence of clinical benefit. The FDA granted the accelerated approval based on data from clinical trials that demonstrated a decrease in beta-amyloid plaque in patients taking the drug.
The FDA advisory committee is made up of independent experts tasked with reviewing data from clinical trials and making recommendations on whether or not the drug should be approved. The committee’s recommendation is not binding, but is often taken into consideration by the FDA when making final approval decisions.
In conclusion, Biogen and Eisai will need to provide additional data and evidence to receive full approval for Aduhelm. The FDA advisory committee will review the data on June 8th and make a recommendation on whether the drug should be approved. The approval of Aduhelm could have a significant impact on the treatment of Alzheimer’s disease, as it has been nearly two decades since a drug for the disease has been approved.