Nine months after the U.S. launch of the first drug proven to slow the progression of Alzheimer’s disease, Eisai and Biogen’s Requemby faces unexpected hurdles to widespread use. That’s a stereotype among some doctors that treating diseases that rob people of their memory is futile.
Alzheimer’s disease experts had anticipated bottlenecks due to Requemby’s requirements, including additional diagnostic tests, twice-monthly IV infusions, and regular brain scans to prevent potentially fatal side effects.
And interviews with 20 neurologists and geriatricians from rural, urban, academic, and community clinics in 19 states show that since the drug was approved by the U.S. Food and Drug Administration, these problems have increased. It has become clear that this is a contributing factor to the delay in widespread use.
FDA gives full approval to ‘novel’ Alzheimer’s disease drug Requemby, making it eligible for Medicare
In interviews with Reuters, seven doctors treating Alzheimer’s patients said their reluctance to prescribe Rekenbi stemmed from concerns about the drug’s effectiveness, cost and risks.
Use of the FDA-approved Alzheimer’s disease drug Requemby has slowed as doctors’ skepticism grows, but patients like Lynn Castellano of St. Louis say the drug offers hope for the future. continues to use. (Reference via Joe Castellano/Reuters)
“I don’t think it’s a good Alzheimer’s drug. I think that’s the problem,” said Dr. James Burke, a neurologist at Ohio State University who has been an outspoken critic of Rekenbi. “It’s certainly not the home run we’re looking for.”
Six other scientists who are leaders in the field argue that “therapeutic nihilism” (the belief that Alzheimer’s disease is a hopelessly incurable disease) can lead patients to primary care physicians, He said that it is playing a bigger role than expected in suppressing the demand for geriatricians and neurologists. Treated by a memory specialist.
Dr. Leisa Sperling, a neurologist and Alzheimer’s disease researcher at Massachusetts General Brigham Hospital in Boston, attributes some doctors’ skepticism to Requembe to a fatalistic attitude toward cancer treatment 30 years ago. For example, he says: Want to get tested? ”
Alex Scott, Eisai’s chief administrative officer, acknowledged that skepticism is weighing on the launch, along with slower-than-expected adoption in large health systems. Ta.
He said some of the hesitation among doctors could be a vestige of decades of research showing that removing the Alzheimer’s disease protein beta-amyloid from the brain can slow the progression of the disease. he suggested. Before Esai announced the promising results of its Requembi trial, some thought the research area was a “fool’s errand,” Scott said.
“We’re starting to make more and more progress every month, so we’re still very encouraged,” Scott said. “This is a new initiative and I think it will take time for providers to understand it.”
“Significant risk, marginal benefit”
Rekenbi became the first amyloid-targeted drug to receive full FDA approval after slowing cognitive decline by 27% in people in the early stages of Alzheimer’s disease in clinical trials.
Eisai announced that of the 10,000 Americans the companies had sought treatment for by the end of March, only a few thousand had started treatment as of the end of January. An Eisai spokeswoman declined to provide updated figures.
Adoption of new drugs is notoriously slow, even for treatments that do not require dramatic changes in medical practice. Some studies estimate that it can take an average of 17 years for clinical research to translate into daily practice.
The disease is estimated to affect more than 6 million Americans, according to the Alzheimer’s Association.
New dementia drug ‘gives me hope’: Alzheimer’s patient says
Less than half of U.S. neurologists recommend Rekenbi to their patients, according to a January survey by life sciences market research firm Spherix Global Insights.
Dr. Michael Gracious, a professor at Stanford University’s Center for Memory Disorders, said there is little evidence that Requembi benefits patients in any meaningful way.
“If you take the trial results at face value, the difference between placebo and treatment is likely small enough to be imperceptible to patients, their families, or their doctors,” said Gracius, who recommends Rekenbi for patients. do not have.
He said the long wait for Alzheimer’s drugs has put doctors in a position where they feel they have to provide treatment “even if the evidence is very poor.”
Other doctors have raised concerns about the risks of brain swelling and bleeding associated with Requemby, as well as the costs associated with the $26,500-a-year drug, frequent MRIs and twice-monthly IV infusions.
“These drugs carry significant risks and are costly, but the benefits are modest,” says Dr. Eric Weidra, a geriatrician and professor at the University of California, San Francisco, who recommends treatments to lower amyloid. I mentioned the law.
Donna Fick, president of the American Geriatrics Society, said in an editorial published in the Journal of Gerontological Nursing in November that the organization recommends the use of lecanemab, sold under the brand name Rekenbi. He advised doctors to take precautions.
“It is not yet clear whether treatments like lecanemab, which clear amyloid from the brain, result in clinically important delays in cognitive decline in Alzheimer’s disease.”
“Your enemy is nihilism”
Dr. Jonathan Riss, a neurologist in Columbus, Georgia, who serves on Eisai’s scientific advisory board and tried Rekenbi in clinical trials, said at a November 2022 meeting following the publication of Rekenbi’s groundbreaking research. He said he was the first to warn about nihilism.
Eisai had asked its scientific advisers how the drug might fare against future rivals. Rhys warned that rivals are not enemies. “Your enemy is nihilism,” he recalled. “All the neurologists around the table started applauding.”
First drug proven to slow Alzheimer’s disease will not be available to most patients for several months
Dr. Nathaniel Chin, a geriatrician at the University of Wisconsin Alzheimer’s Disease Research Center, said he was the target of negative comments on social media after urging geriatricians to embrace such treatments in the Journal of the American Geriatrics Society. Ta.
He said geriatricians, geriatric social workers and nurses disagreed, arguing that the drug’s statistically significant benefits were clinically meaningless for patients, especially when considering the risks.
“I would ask the question, ‘Is it ethical to withhold an FDA-approved, insurance-covered drug from someone who is willing to take the risk?'” Chin said. .
Dr. Priya Singhal, executive vice president and head of development at Biogen, acknowledged some doctors’ apathy toward treatment, but said lack of infrastructure and access to neurologists are bigger problems. Ta.
Singhal said the companies are working with doctors and patient advocacy groups to develop educational programs and materials aimed at diagnosing early-stage patients, managing side effects and understanding the benefits of drugs.
The companies said they aim to increase their sales force by 30% with the aim of reaching 100,000 patients by 2026.
Currently, Requemby is the only commercially available Alzheimer’s disease drug designed to slow the progression of Alzheimer’s disease. A decision on Lilly’s donanemab was delayed until the FDA convenes an advisory committee.
Lilly Neuroscience President Anne White said in an interview that she believes physician hesitancy is a problem and that the company wants to address it by identifying which patients would benefit from such treatments.
She said that in the early stages of Alzheimer’s disease, many patients are still independent, and being able to remain that way for longer would be very meaningful.
‘Peace and tranquility’
Lynn Castellano, 64, who founded and ran a breast cancer charity in St. Louis for 20 years and also trained therapy dogs, struggled to keep appointments and about a year after being diagnosed with mild cognitive impairment. After that, I started taking Rekenbi in September last year. .
Castellano said her biggest concern was the possibility of bleeding in the brain, a possible side effect of the drug, but said her family believed it could slow the progression of the disease.
She is one of more than 140 patients being treated by doctors at Washington University in St. Louis, and has successfully undergone 13 IV fluids and two MRI scans.
Dr. Suzanne Schindler, an Alzheimer’s disease researcher involved in Castellano’s treatment, said Rekembi “is forcing clinicians to completely change the way they practice medicine for years.”
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She was frank about the modest benefits and risks of requembe. She said about 80% of people who she believes are good candidates have chosen this treatment.
Castellano doesn’t know if Requembi is helping, but she says the treatment has given her hope and she doesn’t mind the twice-monthly infusions.
“I go out and sit in a nice chair and read for a few hours with my dog. This is the only place I have peace and quiet.”
