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New Treatment for Alzheimer’s Could Get Soon FDA Approval

new treatment for alzheimer's

New Treatment for Alzheimer’s, The cells in an Alzheimer’s-affected brain are seen in this illustration provided by the National Institute on Aging/National Institutes of Health, where aberrant quantities of the beta-amyloid protein have clumped together to form brown plaques that aggregate between neurons and impair cell function.

Within neurons, abnormal tau protein accumulations build up to form blue tangles that impair synaptic transmission between nerve cells. (via AP, National Institute on Ageing, NIH)

In its drive to develop better treatments for dementia caused by conditions other than Alzheimer’s disease, the scientific community thinks it has made significant progress.

New Treatment for Alzheimer's

Federal officials are anticipated to evaluate and approve Lecanemab’s full approval this week. In clinical trials that lasted 18 months, the bimonthly injection has proven to be helpful in reducing the effects of Alzheimer’s disease by around six months.

“I think it’s a breakthrough saying we can target the pathology of New Treatment for Alzheimer’s disease and make a difference,” said Dr. Judith Heidebrink, a neurologist from Michigan Medicine and the clinical core co-lead of the Michigan Alzheimer’s Disease Centre. New Treatment for Alzheimer’s

“We’d love to stop the advancement or reverse the progression (of the disease), but this is the first step towards these more advantageous medicines that can actually alter how a person’s sickness develops. If we can slow it down for someone with early signs, they will have six months longer of independence in that work.

About Patients:

More than 6.5 million Americans suffer from Alzheimer’s disease, a degenerative brain ailment that steadily robs sufferers of their memory, cognitive abilities, and capacity for simple tasks. An exceptional degree of memory loss, especially in the short term, is the most prevalent early sign of Alzheimer’s disease.

“It’s not just an ‘Oh, what was the name of the actor in that movie I saw yesterday,’ but a ‘Did I go to a movie yesterday or not,'” Dr. Heidebrink said. “Key details, recent occurrences, or conversations are being forgotten. Maybe it happens now and then, but with time it becomes evidently persistent, progressing, and begins to affect daily activities.

Lecanemab, which is manufactured by the Japanese pharmaceutical company Eisai under the trade name Leqembi, received fast approval from the U.S. Food and Drug Administration (FDA) in January. The FDA’s advisory group then unanimously backed the advantages of the medication last month, clearing the door for the FDA to give final clearance by Thursday, July 6.

A monoclonal antibody called acts to prevent the formation of amyloid plaque in an Alzheimer’s patient’s brain. One of two biochemical alterations that take place in a person with the disease’s brain is that plaque. New Treatment for Alzheimer’s

Researchers:

found that early-stage Alzheimer’s patients who received the medication every two weeks for 18 months showed less cognitive impairment than those who received a placebo. Brain imaging, cognitive testing, and interviews with the person’s friends and family were used to quantify decline.

According to Heidebrink, “roughly speaking, the people taking the active medication were functioning and thinking at a level the placebo group was six months earlier.” She also hypothesized that using it for more than 18 months would cause the disease to progress more slowly, however, additional research is required to prove this.

Lecanemab shows promise, but there are logistical and financial obstacles that must be overcome before it can be used, which could cause a sluggish adoption.

Over the course of a year of treatment, Eisai estimates that the cost of its medication will be around $26,500 per person. That excludes the price of routine MRI or PET brain scans to check for adverse effects and verify eligibility.

Medical facilities will need to decide if they want to and are able to provide the therapy after the medicine has received full FDA approval. The extent to which insurance companies will pay for the medicine and additional tests, such as PET scans, which, according to Heidebrink, aren’t often covered but are necessary to establish eligibility, will be up to them.

Other health issues and drugs that can raise the risk of side effects including swelling or bleeding on the brain’s surface may also affect patient eligibility.

“There will be logistical barriers to accessing the technologies that are required to decide who is appropriate for the therapy and to deliver it safely, as well as a shortage of specialists who can say, ‘Yes, this person qualifies based on their symptoms and diagnostic evaluation as well,” Heidebrink explained.

With all of this in mind, she is enthusiastic about the drug’s use starting in late summer or early autumn and gradually spreading. She claims that Lecanemab has already advanced further than many past medicines that failed in clinical trials.

“This is the first drug where we’ve seen a clear clinical benefit rather than just a biological benefit,” she explained.

Heidebrink expects that the latest result will lead to other breakthroughs that cut the cost and provide access to additional medicines. More research, she says, will be important in identifying whether high-risk persons could use the injections as a preventative approach before symptoms appear.

“This may be more like cancer in that you have to understand what stage people are at, and their treatment will depend on whether they are in the asymptomatic stage where the amyloid is silently building up the early symptomatic stage, or are they more advanced,” she explained.

“This is really a big woo,” she exclaimed. “We’ve dealt with a lot of drug failures over the years, and I believe we’re making progress on both the therapeutic and diagnostic fronts.” It’s an exciting moment to be in this industry.”

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Amelia Jhon

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