FDA Grants Accelerated Approval To New Alzheimer’s Drug
Food And Drug Administration Headquarters In Maryland WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images) Sarah Silbiger / Stringer
Photo by Sarah Silbiger/Stringer/Getty Images

The U.S. Food and Drug Administration (FDA) granted accelerated approval for a new drug designed to treat Alzheimer’s on Friday.

The drug is Leqembi, which was created by Japanese pharmaceutical company Eisai, which will work with Biogen in order to market and commercialize it. The accelerated approval is based on a small study that showed patients who were given the drug “had significant dose- and time-dependent reduction of amyloid beta plaque,” which is an indicator of Alzheimer’s.

When someone has Alzheimer’s disease, amounts of the beta-amyloid protein group together to create plaques in between neurons, impacting how the cells work.

The drug’s price will be an annual $26,500 for someone who is of average weight. Medicare has not said it will cover the treatment yet.

Experts of the disease said that the drug offers modest advantages for people who have minor cognitive impairment or early Alzheimer’s disease.

The approval brings to mind Aduhelm, another Alzheimer’s treatment that was approved by the FDA in June of 2021. The drug was created by Biogen and many Alzheimer’s scientists spoke out against it. Due to unknown upsides and potential brain swelling and bleeding risks, large health groups chose not to even provide the drug. The treatment was eventually put aside in the marketplace after Medicare restricted its coverage of it. Eisai was working with Biogen on the drug, but bowed out last year.

A congressional investigation put forward in December discovered that the FDA’s procedure for approving Aduhelm was “rife with irregularities.” The agency’s work with Biogen was questionable. The investigation also found that Biogen put a high cost on the drug.

Democratic Representative Frank Pallone of New Jersey said in a statement that 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.”

The FDA’s own internal inquiry, done before the drug was greenlit, discovered that people at 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. It also found that its work with Biogen, the maker of the drug, “exceeded the norm in some respects.”

The new drug, Leqembi, still poses some potential dangers. The FDA noted that it is incorporating a warning for Leqembi over amyloid-related imaging abnormalities (ARIA), which can lead to life-threatening and serious situations, but typically no symptoms are present.

“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 noted.

It said the most frequent side effects were headache, ARIA, and “infusion-related reactions.”

The FDA will also contemplate final approval after it receives more information from a larger study by the company in a few days, which is something it didn’t do with Adehulm, which was also approved in the accelerated format.

The larger, 18-month study of Leqembi revealed that 17.3% of patients using the treatment experienced indications of brain bleeding, while 9% of the placebo group had it. Signs of swelling of the brain also happened in 12.6% of those who took Leqembi, compared with 1.7% of those who were on the placebo. “[S]erious adverse events” happened in 14% of those taking Leqembi and 11% of those who got the placebo. Almost 7% of people on Leqembi ended the trial due to adverse side effects, which was more than double the percentage of people who quit who were taking the placebo.

Physicians also reportedly said that side effects can be managed with appropriate watchfulness and most patients don’t have unpleasant symptoms. If scans do find swelling or bleeding, the patient can temporarily stop receiving the drug.

But there is also concern for people who are taking blood thinners. Three people who took the medicine passed away while on it, but Eisai said the fatalities can’t be blamed on the medicine. Two of the deceased were taking blood thinners.

The company’s clinical trial also proposed that Leqembi won’t work for around 10% of people who have two copies of APOE4, and they could be hurt by the drug. APOE4 is the most frequent genetic risk factor for the disease. Around 25% of people have one copy of it, and 2% to 3% of people have two copies.

The study showed that people who took the drug were 31% less likely to continue to the next stage of Alzheimer’s while in the study. One kind of swelling was experienced in around 13% of people who got the drug. The treatment also put off the patients’ deterioration by around five months during the study, although the measurement of the decline was not as much as some would have preferred.

“It is unlikely that the small difference reported in this trial will be noticeable by individual patients,” Dr. Madhav Thambisetty of the National Institute on Aging, said in November. He clarified he wasn’t speaking on behalf of the agency.

Some doctors said they will prescribe the drug for patients for whom it might be beneficial, but others caution that it might not do a lot. Physicians also note that its impact isn’t strong and it isn’t the same as a cure.

“Most patients won’t notice the difference,” Dr. Matthew Schrag, a neurology researcher at Vanderbilt University, said. “This is really quite a small effect and probably below the threshold of what we’d call clinically significant.”

Schrag said there is “less drama” for Leqembi when compared with Aduhelm, but he noted that a lot of the similar worries are still there.

“Is this slight, measurable benefit worth the hefty price tag and the side effects patients may experience?” he asked. “I have pretty serious doubts.”

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