New Drug for Alzheimer

FDA Approves Biogen's Alzheimer's Drug Aducanumab

The Food and Drug Administration (FDA) has approved Biogen's Alzheimer's disease drug aducanumab, making it the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer's and the first new medicine for the disease in nearly two decades. The drug, which is marketed under the name Aduhelm, is also expected to generate billions of dollars in revenue for the company.

Aducanumab was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. The drug reduces beta-amyloid plaques, which is reasonably likely to lead to a reduction in clinical decline due to Alzheimer’s disease. Aducanumab was the first therapy to demonstrate that removing beta-amyloid, one of the hallmarks of Alzheimer’s disease, from the brain reduces cognitive and functional decline in people living with early Alzheimer’s

The approval of Aduhelm is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain. There were previously no drugs cleared by the FDA that can slow the mental decline from Alzheimer's, which is the sixth-leading cause of death in the United States. The agency has approved Alzheimer's drugs aimed at helping symptoms, not actually slowing the disease itself.

However, the approval of Aduhelm has been controversial. The FDA's independent advisory committee and some Alzheimer's experts opposed the decision, saying there was not enough evidence that the drug can help patients. The drug's high price, which is expected to be around $56,000 per year, has also been criticized.

The FDA has required Biogen to conduct a new clinical trial to verify the drug's clinical benefit. If the new trial, called a Phase 4 trial, fails to show the drug is effective, the FDA can rescind its approval.

The need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimer’s disease, and this number is expected to grow as the population ages. Alzheimer's is the sixth leading cause of death in the United States.

Mechanism of action of aducanumab in treating Alzheimer's disease.

A monoclonal IgG1 antibody called aducanumab binds to amyloid- and lowers amyloid plaques in the brain. Auranumab differs from other modern A immunotherapeutic drugs in that it preferentially binds amyloid aggregates in both the oligomeric and fibrillar phases as opposed to amyloid monomers. By stopping and eliminating beta-amyloid pathology, the medication was created to slow the progression of Alzheimer's disease. Based on the Mini-Mental State Examination, Clinical Dementia Rating, and levels of p-tau in the cerebrospinal fluid, aducanumab medication is connected to a slower rate of Alzheimer's disease progression. Acuranumab was discovered to bind to and promote the clearance of parenchymal plaques in Tg2576 mice without inducing microhemorrhages. Aducanumab decreases beta-amyloid plaques, which is probably going to prevent clinical decline from Alzheimer's from getting worse.

Effectiveness of aducanumab in treating Alzheimer's disease.

Auranumab's ability to effectively treat Alzheimer's disease has generated debate. What the search results say is as follows:

Aducanumab was created to stop and eliminate beta-amyloid pathology and slow the progression of Alzheimer's disease.

The first treatment to show that eliminating beta-amyloid, one of the symptoms of Alzheimer's disease, from the brain slows cognitive and functional deterioration in those with early-stage Alzheimer's was aducanumab.

Based on the Mini-Mental State Examination, Clinical Dementia Rating, and levels of p-tau in the cerebrospinal fluid, aducanumab medication is connected to a slower rate of Alzheimer's disease progression.

Alzheimer's disease is suggested for treatment with aducanumab. Patients with moderate cognitive impairment or mild dementia stage of disease, the population in which treatment was started in clinical trials, should begin treatment.

Alzheimer's disease cannot be cured or reversed by aducanumab. It decreased amyloid plaque levels in 2 clinical studies after 18 months, but in 1 trial there was no clinical effect and in the second there was a substantial effect.

Aducanumab falls short of almost all requirements: it has serious safety issues, is ineffective, expensive, and difficult to administer and monitor.

The effectiveness of aducanumab in enhancing cognitive function and delaying the onset of Alzheimer's disease has been questioned, despite evidence that it reduces beta-amyloid plaques in the brain, which is likely to prevent clinical decline brought on by Alzheimer's disease. To confirm the drug's clinical benefit, the FDA has mandated that Biogen carry out a fresh clinical investigation.