What to Know About Newly Approved Drug
The recently approved drug is Aducanumab, which received approval from the US Food and Drug Administration (FDA) for the treatment of Alzheimer's disease. Here are some important aspects about Aducanumab:
Indication: Aducanumab is indicated for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease and mild Alzheimer's dementia.
Mechanism of Action: Aducanumab is a monoclonal antibody that targets the aggregated forms of amyloid-beta, specifically the amyloid-beta plaques that accumulate in the brain in Alzheimer's disease. By binding to these aggregates, Aducanumab aims to reduce the levels of amyloid-beta and potentially slow down the progression of the disease.
Clinical Trials: The approval of Aducanumab was based on the results from two Phase 3 clinical trials called ENGAGE and EMERGE. ENGAGE did not meet the primary endpoint, while EMERGE showed a statistically significant reduction in clinical decline in patients who received Aducanumab compared to a placebo.
Dosing and Administration: Aducanumab is administered as an intravenous infusion. The recommended starting dose is 10 mg per kilogram, given every four weeks. The dose may be increased to 20 mg per kilogram after a certain period if the initial response is favorable and there are no significant side effects.
Common Side Effects: Common side effects associated with Aducanumab in clinical trials included:
-Brain edema (swelling of the brain) or micro-hemorrhages
-Headache
-Dizziness
-Fatigue
-Confusion
-Nausea
-Vomiting
-Skin reactions at injection site
Controversies: The approval of Aducanumab was controversial due to mixed scientific opinions and concerns about potential harms and lack of substantial clinical benefit demonstrated in clinical trials. Some experts raised concerns about the validity and interpretation of the clinical trial data.
Ongoing Research: Longer-term studies are needed to further assess the safety and effectiveness of Aducanumab and its impact on the progression of Alzheimer's disease.
Importance: Aducanumab represents a significant milestone as the first disease-modifying therapy specifically targeting amyloid-beta in Alzheimer's disease to receive FDA approval. It is the first new Alzheimer's treatment approved by the FDA in nearly 20 years. However, its clinical benefits and associated risks need to be carefully considered, and close monitoring is necessary for patients under treatment.
Despite the approval of Aducanumab, the broader conversation about Alzheimer's disease treatment remains challenging, with ongoing discussion and research to find effective therapies and improve outcomes for individuals living with this debilitating disease.