According to sources, the FDA today has granted approval for Aduhelm as a new drug for Alzheimer’s therapeutics, which currently affects over 6 million Americans.
The drug has been approved based on Accelerated Approval practices that consider surrogate endpoints to determine a particular drug’s efficacy and clinical benefits. Accelerated approval is limited to drug approvals of critical medical conditions with massive medical care delivery gaps.
Life-threatening ailments such as Alzheimer’s, which also massively degrade patients’ quality of life, require expedited medical means for systematic management.
Therefore, to avoid further deterioration and loss of time and resources in effective disease management, the FDA today has approved the Aduhelm drug via accelerated approval.
Addressing the event, FDA Director of the Center for Drug Evaluation and Research has pointed out that a lack of quick and reliable therapeutic means may have irreversible implications on Alzheimer’s patients, affecting the lives of the kith and kin.
Adding further, she also emphasized, currently available therapeutic means have an asymptomatic approach in disease management.
With this latest approval in place, underlying disease conditions could be better gauged and tackled.
Patrizia has also vouched for an accelerated approval pathway as an ideal method to benefit treatment while encouraging further R&D expeditions in the field.
Adehelm is the first therapeutic drug that has received FDA approval since 2003. It primarily targets the basic pathophysiology of Alzheimer’s.
The disease is a degenerative brain disorder that gradually impairs the patient’s memory, cognitive abilities, and basic skills required for daily chores and tasks.
The latest breakthrough in Aduhelm is anticipated to improve disease management significantly.