Unlike currently available therapies – which only treat symptoms of the diseases – Aduhelm is the first therapy to target and affect the underlying diseases process of Alzheimer’s, notes the FDA.
“As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research.
The monoclonal antibody has been approved using the FDA’s accelerated approval pathway, which is designed for drugs for serious or life-threatening illnesses ‘that provides a meaningful therapeutic advantage over existing treatments’.
Under this pathway, the FDA requires Biogen to conduct a new randomized controlled clinical trial to verify the drug’s clinical benefit.
Milestone decision
The FDA’s decision has been the center of attention. Alzheimer’s affects 6.2 million Americans, a devastating illness that can have a profound impact on patients and their families.
And yet the FDA acknowledges that data for the drug are ‘complicated with respect to its clinical benefits’.
Aduhelm received a large setback in November, when the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee reviewed clinical trial data and said it did not believe one successful trial could act as the primary evidence supporting approval.
But in approving the treatment today, the FDA says it ”has determined that there is substantial evidence that aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients.”