Eisai, Biogen’s Alzheimer’s medication, receives complete approval from an FDA panel

Alzheimer's

The Food and Drug Administration is more likely to extend expanded approval to a closely watched medication for Alzheimer’s disease now that it has received renewed support from a group of brain health experts. During a conference on Friday, the experts decided 6-0 that newly obtained clinical trial data confirm that the therapy, known as Leqembi, aids Alzheimer’s sufferers.

The FDA is considering whether to convert a conditional approval granted to Leqembi earlier this year into a complete approval, and the committee’s findings may sway the agency in that direction.
Although the FDA is not compelled to accept the advice of its experts, it usually does. The agency must decide whether to increase Leqembi’s label by July 6.

Such a result could significantly boost the number of patients who can obtain Leqembi and other related Alzheimer’s medications. Currently, the government insurance program Medicare, which covers the vast majority of patients eligible for these prescriptions, has a rigorous access restriction in place. However, if Leqembi receives full clearance, the program has indicated that it will reduce its reimbursement requirements. With increased insurance coverage, Wall Street analysts anticipate Leqembi will become a blockbuster medicine for its makers Eisai and Biogen.

The team at RBC Capital Markets, for example, anticipates that the medicine would eventually produce up to $10 billion in yearly sales. Leqembi’s conditional approval was based on an 850-person research that convinced FDA staff that it was reasonably likely to benefit Alzheimer’s sufferers. To corroborate those findings, Eisai and Biogen conducted a bigger, nearly 1,800-person experiment, the results of which were published in September.

The major goal of the research was met, as subjects decreased 27% slower when administered Leqembi vs a placebo, as determined by a scale designed to assess mental and physical function. The experiment also included other well-known tests for Alzheimer’s patients, and positive results supported Leqembi’s efficacy. Since those findings were made public, Alzheimer’s specialists have discussed the influence a medication like Leqembi could have on patients.

Some regard the drug as a significant accomplishment in an area rife with failure, while others say it provides just minor benefits at best. FDA employees appear to be more optimistic about the medicine. According to Teresa Buracchio, acting head of the FDA’s Center for Drug Evaluation and Research’s neuroscience office, their findings are “generally consistent with the results presented.” Furthermore, the methods used to collect and evaluate data from the bigger study “capture the symptoms and impacts of Alzheimer’s disease that are meaningful to patients.”

More About Alzheimer’s disease

Alzheimer’s disease is a progressive neurodegenerative disorder that primarily affects the brain, leading to memory loss, cognitive decline, and behavioral changes. It is the most common cause of dementia, accounting for around 60-80% of all cases.

Here are some key points about Alzheimer’s disease:

  1. Symptoms: Alzheimer’s disease typically starts with mild memory loss and difficulty in remembering recent events. As the disease progresses, individuals may experience confusion, disorientation, problems with language and communication, mood swings, loss of motivation, and eventually, a decline in the ability to perform daily tasks.
  2. Causes: The exact cause of Alzheimer’s disease is not fully understood, but it is believed to be a combination of genetic, environmental, and lifestyle factors. Certain genes, such as the APOE gene, are associated with an increased risk of developing the disease. Age is also a significant risk factor, as the prevalence of Alzheimer’s increases with advancing age.
  3. Brain changes: Alzheimer’s disease is characterized by the accumulation of abnormal protein deposits in the brain, including beta-amyloid plaques and tau tangles. These deposits disrupt the normal functioning of brain cells, leading to their degeneration and death.
  4. Diagnosis: Alzheimer’s disease is primarily diagnosed based on a thorough medical history, cognitive assessments, and ruling out other possible causes of symptoms. Brain imaging techniques, such as MRI or PET scans, may be used to support the diagnosis and assess the extent of brain changes.
  5. Treatment: Currently, there is no cure for Alzheimer’s disease, and available treatments aim to manage symptoms, slow down the progression of the disease, and improve quality of life. Medications, such as cholinesterase inhibitors and memantine, are commonly prescribed to help manage cognitive symptoms. Non-drug approaches, including cognitive stimulation, physical exercise, and social engagement, may also be beneficial.
  6. Ongoing research: Scientists and researchers are actively studying Alzheimer’s disease to understand its underlying mechanisms and develop effective treatments. Advances in genetics, neuroimaging, and biomarker research are providing new insights into the early detection and potential future therapies.

It’s important to note that if you or someone you know is experiencing symptoms of Alzheimer’s disease or any cognitive impairment, it is recommended to consult with a healthcare professional for a proper evaluation and guidance.

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