Blog FDA Approves Alzheimer’s Treatment, Doctors Relieved

FDA Approves Alzheimer’s Treatment, Doctors Relieved

The U.S. Food and Drug Administration fully approved the recently developed drug for treating Alzheimer’s. The approval comes at a crucial time when scientific advances bring researchers closer to the chemistry behind this progressive disease. 

The approved drug is second in the new category of treatment advised for Alzheimer’s, which specifically targets the pathophysiology of this type of dementia. A significant advancement in the effective treatment of Alzheimer’s disease, Leqembi showed positive results for research participants. 

The approval was received through the Accelerated Approval pathway, the process for the FDA to approve drugs developed for severe conditions such as Alzheimer’s. 

Researchers tested the drug’s effectiveness in a double-masked, dose-finding, placebo-controlled study with 850-odd participants. The study was initiated with patients who had mild impairment in cognition. The researchers confirmed the presence of amyloid beta plaque in the participants. This is a marker of this condition, allowing doctors to detect it in patients who may not show symptoms. 

The accelerated approval of the drug is made possible after the observation that the participants showed low levels of amyloid beta plaque. The researchers thoroughly studied the side effects of the drug and concluded that some detrimental effects could be observed in some participants. 

The side effects ranged from confusion, nausea, dizziness, seizures, and vision changes, with some participants showing signs of modifications in blood pressure, headache, and flu-like symptoms, categorized as infusion-related reactions. 

The other side effects of the drug included amyloid-related imaging abnormalities, which is a warning issued in the prescribing information. ARIA is not reported to have symptoms. However, some life-threatening events may also be observed in the patients. 

The FDA indicated the drug for Alzheimer’s, specifically for patients experiencing mild dementia and cognitive impairment. And cleared that there are no safety-related issues with starting the treatment earlier or later in the stages of the disease. 

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