Alzheimer’s Disease Treatment Receives Accelerated Approval From FDA

The U.S. Food and Drug Administration (FDA) approved Leqembi on Friday for the treatment of Alzheimer’s disease. The Centers for Disease Control (CDC) says as many as 5.8 million Americans had Alzheimer’s disease in 2020.

On Friday, the FDA approved a new Alzheimer’s disease treatment produced by Eisai Co., Ltd., and Biogen Inc. through the Accelerated Approval pathway. The new drug titled Leqembi (lecanemab-irmb) highlights advancements in treatments for patients battling Alzheimer’s disease.

As the baby boomer generation ages, Alzheimer’s cases are expected to rise. According to the Alzheimer's Association, By the year 2050, an estimated 12.7 million people over the age of 65 will have Alzheimer’s in the U.S.

"Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,... This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease."

Billy Dunn M.D.

In a news release, Director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, Billy Dunn (M.D.), emphasized the importance of the new discoveries for individuals diagnosed with Alzheimer’s disease.

What is the Accelerated Approval pathway?

Research on the effectiveness of a drug can take years, which caused the FDA to institute Accelerated Approval regulations in 1992. The FDA says the regulation allows drugs for serious conditions that fill an unmet medical need to be approved based on success in clinical trials.

During the Obama Administration in 2012, Congress passed the Food and Drug Administration Safety Innovations Act (FDASIA). Section 901 of the act amends the Federal Food, Drug, and Cosmetic Act (FD&C Act). This gives the FDA the ability to approve drugs for serious conditions that have few available treatments as long as the drug has an effect on a surrogate or an intermediate clinical endpoint.

Research on 856 Alzheimer’s patients found patients receiving Leqembi showed a significant reduction in brain amyloid plaque from the beginning of the study until its conclusion compared to the placebo groups. The drug is intended for patients with mild symptoms of Alzheimer’s disease.

Leqembi is administered via an intravenous infusion every two weeks. An intravenous infusion is also known as IV therapy, a medical technique of putting fluids, including drugs, into the bloodstream.

Chief Executive Officer at Eisai, Haruo Naito, praised the FDA’s quickness in approving the new Alzheimer's treatment.

"We deeply appreciate the cooperation of people living with Alzheimer’s disease and healthcare professionals who participated in LEQEMBI’s Phase 3 Clarity AD clinical study, which enabled us to submit this sBLA,... The fact that Eisai was able to file LEQEMBI’s supplemental Biologics License Application for traditional FDA approval on the same day we received accelerated approval demonstrates our commitment to the Alzheimer’s disease community and is a major step forward in ensuring access for all those in the U.S living with this disease in need of this medicine. We will continue to actively cooperate with the FDA's review."

Chief Executive Officer at Eisai, Haruo Naito

Some Side effects of Leqembi may include:

  • Headaches
  • Cough
  • Diarrhea
  • Infusion-related reactions featuring flu-like symptoms
  • Amyloid-related imaging abnormalities

Alzheimer’s disease on the rise

Alzheimer’s disease is the most common form of dementia, beginning with mild memory loss and leading to loss of function in most daily activities. The CDC says the number of Americans living with the disease doubles every five years beyond age 65. Recently, a Healthnews article explored a study evaluating the effect of nature. While there is no cure for Alzheimer’s disease, steps can be taken to slow down its progress.

Lifestyle improvements to combat Alzheimer’s disease include healthy eating featuring fruits and vegetables, and leaner meats versus processed meats. Also, maintaining levels of fitness, eliminating smoking, consuming alcohol in moderation, and having good sleeping habits can help against the disease.

Alzheimer’s stages vary in symptoms. The mild or early stage includes some forgetfulness that may appear in relation to aging. The individual may be independent, but struggle to recall names, events, and plans, or struggle with organization — including valuable objects or money management.

The Moderate stage is the longest stage in most cases, lasting up to years. Symptoms include increased trouble remembering events, failure to learn new things, a hard time planning events, or remembering details about their own life.

As the moderate stage progresses, patients may have increased stress, anxiousness, lose track of time or place, and require assistance with daily activities such as getting dressed.

In the severe stage, a patient may lose the ability to walk, sit, or eat. Also, bladder and bowel control issues may exist. Late-stage patients require constant help with all activities and may be unaware of their recent events or surroundings.

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