Abdullah Abu Deif (Cairo)
The US Food and Drug Administration has announced Aduhelm (aducanumab) to treat Alzheimer’s disease, a debilitating disease that affects 6.2 million Americans. Aduhelm has been approved using the accelerated approval pathway, which can be used for a drug for serious or life-threatening illness and provides a meaningful therapeutic advantage over existing treatments. .
Expedited approval can be based on a drug’s effect on an alternative endpoint that is reasonably likely to predict clinical benefit for patients, with a trial required after approval to verify that the drug provides the expected clinical benefit. Patricia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said: Alzheimer’s disease is a devastating disease that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones, currently available treatments treat only the symptoms of the disease This treatment option is the first treatment that targets and affects the underlying disease process of Alzheimer’s disease As we have learned from fighting cancer The accelerated approval pathway could deliver treatments to patients faster while stimulating more research and innovation.” Aduhelm represents the first approved treatment for Alzheimer’s disease, the first new treatment approved for Alzheimer’s disease since 2003 and the first to target the underlying pathophysiology of the disease.
The researchers evaluated the efficacy of Aduhelm in three separate studies representing a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose range studies in Alzheimer’s patients. Patients receiving treatment had a significant dose- and time-dependent reduction in beta-amyloid plaque, whereas patients in the control arm of the studies had no reduction in beta-amyloid plaque. Aduhelm has been awarded the Fast Track designation, which seeks to accelerate the development and review of drugs intended to treat serious conditions where preliminary evidence has shown that an unmet medical need can be met.