FDA approves groundbreaking Alzheimer’s drug Leqembi — here’s why patients still won’t have access

After months of anticipation, the U.S. Food and Drug Administration (FDA) has finally granted traditional approval to lecemab, a drug that’s been shown to significantly slow the progression of Alzheimer’s.

Sold under the the brand name Leqembi, the medicine received an accelerated approval in January but the designation was made official on Thursday, per an FDA press release.

“Today marks a breakthrough in the treatment of Alzheimer’s disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable,” declared Christopher A. Viehbacher president and CEO of pharmaceutical firm Biogen, which created the drug in collaboration with fellow drugmaker Eisai, CBS reported.

Lecemab is the first ever drug that’s been proven to delay the progression of Alzheimer’s, a debilitating neurological disease that gets worse over time, leading to a decline in thinking and memory, lack of mobility and other life-altering complications.

The drug helps slow these symptoms by going after the “underlying disease process,” Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release.

It specifically works by works by reducing amyloid plaques that develop in the brain — a defining characteristic of the disease, per the FDA release.

Leqembi’s preliminary green light in January was based on “robust” clinical trials on people with mild cognitive impairment or Alzheimer’s dementia.

Participants who were given the drug — which is given via infusion — experienced a 27% slower decline in cognitive abilities compared to the ones who received a placebo.

Meanwhile, the former also displayed a superior capacity to perform daily tasks such as dressing and feeding themselves.

In light of the positive trials, FDA committee members unanimously voted that the results “verified that it [lecemab] is a safe and effective treatment for patients with Alzheimer’s disease,” noted Burrachio.

Biogen boss Viehbacher said in a statement said they’ll be working to make [Leqembi] “accessible to eligible patients as soon as possible.”

Despite the inspiring study, experts caution that the medicine is not an Alzheimer’s cure — which currently doesn’t exist, per the Mayo Clinic — but rather a mitigatory measure.

“It doesn’t stop people from getting worse, but it does measurably slow the progression of the disease,” St. Louis neurologist Dr. Joy Snide told The Associated Press in January. “That might mean someone could have an extra six months to a year of being able to drive.”

And, of course, Leqembi is not without side effects, which include infusion site reactions and brain swelling, known as amyloid-related imaging abnormalities, or ARIA.

Lecemab’s label even comes with a warning about the risks of ARIA, cautioning doctors to monitor patients for signs of ARIA using MRIs of the brain.

One of the biggest roadblocks, of course, is the steep price, which clocks in at $26,500 for a year’s worth of treatment sans insurance coverage.

In addition, the Centers for Medicare and Medicaid Services (CMS) — which controls Medicare — will only foot the bill for lecemab patients who enroll in a national registry that does not yet exist and doesn’t have any info on how or when doctors or caregivers would sign up for it.

This condition “is an unnecessary and potentially harmful barrier,” the Alzheimer’s Association lamented.

CMS head Chiquita Brooks-Lasure has since pledged “cover this medication broadly” in the future.

This would be enormously beneficial to both patients and society as a whole: Researchers found that covering new and effective drugs for Alzheimer’s and other forms of dementia would save taxpayers between $13.1 billion and $545.6 billion in healthcare costs over the course of 17 years.

Bureaucratic hurdles notwithstanding, lecemab’s approval marks a significant breakthrough in the fight against Alzheimer’s, which currently affects 6.5 million people in the US.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Dr. Billy Dunn, former director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, declared in a press release. “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.”

While Alzheimer’s currently doesn’t have a cure, scientists have developed ways to potentially reverse its effects.

In April, tests on mice at MIT revealed that tinkering with an enzyme typically found to be overactive in the brains of Alzheimer’s patients causes myriad benefits, including reductions in DNA damage, neural inflammation, and neuron loss that are associated with the disease.

The potential treatment also showed strong results in mending the brain’s tau protein, which when altered, becomes a main characteristic of the condition.