On Friday, the U.S. Food and Drug Administration (FDA) granted accelerated approval for a new drug designed to treat Alzheimer’s.
A small trial that revealed individuals receiving the medication “had significant dose- and time-dependent reduction of amyloid beta plaque,” an indication of Alzheimer’s, is what led to the speedy approval. The drug is Leqembi, which was created by the Japanese pharmaceutical company Eisai, which will work with Biogen in order to market and commercialize it.
Altering how the cells work, the beta-amyloid protein aggregates into plaques between neurons in people with Alzheimer’s disease.
Medicare has not said it will cover the treatment yet. However, the drug’s price will be an annual $26,500 for someone who is of average weight.
For those people with mild cognitive impairment or early-stage Alzheimer’s disease, Experts of the disease said the drug offers modest advantages for them.
In June of 202, Aduhelm, another Alzheimer’s treatment that was approved by the FDA seems to mind following the approval. But Due to unknown upsides and potential brain swelling and bleeding risks, large health groups chose not to even provide the drug. As Biogen developed the drug, many Alzheimer’s researchers spoke out against it. After Medicare limited its coverage, the treatment was eventually reserved in the marketplace. Eisai was collaborating with Biogen on the drug until last year.
The agency’s work with Biogen was questionable, the investigation also found that Biogen put a high cost on the drug. A congressional investigation put forward in December discovered that the FDA’s procedure for approving Aduhelm was “rife with irregularities.”
The findings “[document] the atypical F.D.A. review process and corporate greed that preceded F.D.A.’s controversial decision to grant accelerated approval to Aduhelm,” Democratic Representative Frank Pallone of New Jersey said in a statement.
Aside from that it discovered that its collaboration with the drug’s manufacturer, Biogen, “exceeded the norm in some respects.” The agency didn’t listen closely enough to opposing opinions from the FDA’s statistical team, which argued that there wasn’t enough proof that the drug was successful, as the FDA conducted its own internal investigation before the drug was greenlit.
The FDA noted that it is incorporating a warning for Leqembi, stating that the new drug, Leqembi, still poses some potential dangers. Which can lead to life-threatening and serious situations, but typically no symptoms are present regarding amyloid-related imaging abnormalities (ARIA).
It noted that the “ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain, though some people may have symptoms such as headache, confusion, dizziness, vision changes, nausea and seizure.” It also stated that headaches, ARIA, and “infusion-related responses” were the most typical side effects.
The FDA won’t do this with Adehulm, which was also approved in the accelerated format, but it will do so if it receives further data from a larger trial by the company in a few days.
Nearly 7% of trial participants receiving Leqembi stopped owing to negative side effects, more than twice as many as those taking the placebo. According to an 18-month study of Leqembi revealed, In comparison to 1.7% of those taking the placebo, 12.6% of those on Leqembi experienced signs of brain swelling. Serious side effects occurred in 14% of Leqembi patients and 11% of placebo patients. And 17.3% of patients receiving the medication showed signs of brain bleeding, compared to 9% of those receiving a placebo.
According to reports, doctors also stated that most patients don’t have terrible side effects and that they may be controlled with adequate caution. The patient may temporarily cease taking the medication if scans reveal swelling or bleeding.
People who use blood thinners, however, are also a worry. Eisai claimed that the deaths of three patients who took the medication cannot be attributed to the drug. Blood thinners were being used by two of the deceased.
Leqembi won’t work for about 10% of patients who have two copies of APOE4, according to the company’s clinical trial, and they may have negative side effects. The most common genetic risk factor for the illness is APOE4. One copy is owned by about 25% of people, and two copies are owned by 2% to 3% of people.
Although the measurement of the decrease was not as great as some would have liked, the medication also delayed the patients’ deterioration by about five months during the research. As according to the study, those who took the medication had a 31% lower chance of progressing to the next stage of Alzheimer’s disease. 13% or so of those who took the medication suffered one type of edema.
In November, Dr. Madhav Thambisetty of the National Institute on Aging stated. He made it clear he wasn’t speaking on the organization’s behalf. He said, “It is unlikely that the small difference reported in this trial will be noticeable by individual patients.”
Doctors point out that it doesn’t have a significant effect and isn’t the same as a cure. While some doctors stated they will administer the medication to people for whom it might be helpful, others have issued a warning that it might not have much of an impact.
Dr. Matthew Schrag, a neurology researcher at Vanderbilt University, said, “Most patients won’t notice the difference. This is really quite a small effect and probably below the threshold of what we’d call clinically significant.”
When compared to Aduhelm, Leqembi, according to Schrag, has “less drama,” but many of the same concerns still exist. “Is this slight, measurable benefit worth the hefty price tag and the side effects patients may experience? I have pretty serious doubts,” he asked.