The Alzheimer's drug lecanemab, developed by Eisai Co Ltd and Biogen Inc, was approved by the US Food and Drug Administration on Friday for patients in the early stages of the mind-wasting disease.
Eisai and Biogen announced on Saturday that the Japanese pharmaceutical company had applied for full FDA approval of the drug.
The drug, to be marketed as Leqembi, is part of a class of treatments aimed at slowing the progression of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.
Almost every previous experimental drug that took the same approach had failed.
“Today’s news is incredibly important," said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation. "Our years of research into what is arguably the most complex disease humans face is paying off and it gives us hope that we can make Alzheimer’s not just treatable, but preventable."
Eisai stated that the drug would be available for $26,500 per year. Biogen shares were up 3% at $279.40 after being halted.
The Japanese company also stated that it intends to apply for Leqembi marketing authorization in Japan and the European Union by the end of its fiscal year on March 31.
Eisai predicted that the number of patients eligible for the drug in the United States would reach 100,000 within three years, gradually increasing from there in the medium to long term.
Dr. Erik Musiek, a Washington University neurologist at Barnes-Jewish Hospital, said the drug's cost "pleasantly surprised" him.
"Considering the marketplace and the fact that we have no other good disease-modifying treatments, I think it's in the ballpark of what I would expect," he said.
Initial patient access will be hampered by a variety of factors, including reimbursement restrictions imposed by Medicare, the United States' government insurance program for Americans aged 65 and older, who account for approximately 90% of those who are likely to be eligible for Leqembi.
"Without Centers for Medicare & Medicaid Services (CMS) and insurance coverage ... access for those who could benefit from the newly-approved treatment will only be available to those who can pay out-of-pocket," the Alzheimer's Association said in a statement.
Leqembi was approved through the FDA's accelerated review process, which expedites drug access based on its impact on underlying disease-related biomarkers thought to predict clinical benefit.
“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,” FDA neuroscience official Billy Dunn said in a statement.
CMS announced on Friday that current coverage restrictions for drugs approved through the accelerated pathway may be reconsidered based on its ongoing review of available data.
CMS stated that if the drug receives traditional FDA approval, it will provide broader coverage. According to Eisai officials, the company intends to submit data from a recent successful clinical trial involving 1,800 patients as the foundation for a full standard review of Leqembi.
The CMS decision was largely in response to Eisai and Biogen's previous Alzheimer's treatment. Aducanumab, marketed as Aduhelm, was granted accelerated approval in 2021 despite little evidence that it slowed cognitive decline and despite objections from the FDA's outside experts.
Aduhelm was initially priced at $56,000 per year before Biogen cut the price in half. Sales were only $4.5 million in the first nine months of 2022 due to limited acceptance and insurance coverage.
Lecanemab is intended for patients with mild cognitive impairment or early Alzheimer's dementia, a population that doctors believe is a small subset of the estimated 6 million Americans who suffer from the memory-robbing disease.
To receive the treatment, patients must first be tested for amyloid deposits in their brain, either through brain imaging or a spinal tap. They will also need to have regular MRI scans to check for brain swelling, a potentially serious side effect of this type of drug.
According to the label, doctors should exercise caution when giving blood clot preventers to lecanemab patients. According to an autopsy analysis published this week of a lecanemab patient who had a stroke and later died, this could pose a safety risk.
Lecanemab, which is administered via infusion, slowed the rate of cognitive decline in patients with early Alzheimer's disease by 27% when compared to a placebo in a large trial. In the trial, nearly 13% of patients receiving Leqembi experienced brain swelling.
According to Dr. Babak Tousi, a neuro-geriatrician at the Cleveland Clinic, the approval will make a "significant difference" in the field because it is based on biomarkers rather than symptoms.
"It's going to change how we make a diagnosis for Alzheimer's disease, with more accuracy," he said.
Tousi admitted that the drug's benefit will most likely be marginal. "However, it is a benefit that we were unable to achieve" prior to this approval.
(Source:www.usatoday.com)
Eisai and Biogen announced on Saturday that the Japanese pharmaceutical company had applied for full FDA approval of the drug.
The drug, to be marketed as Leqembi, is part of a class of treatments aimed at slowing the progression of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.
Almost every previous experimental drug that took the same approach had failed.
“Today’s news is incredibly important," said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation. "Our years of research into what is arguably the most complex disease humans face is paying off and it gives us hope that we can make Alzheimer’s not just treatable, but preventable."
Eisai stated that the drug would be available for $26,500 per year. Biogen shares were up 3% at $279.40 after being halted.
The Japanese company also stated that it intends to apply for Leqembi marketing authorization in Japan and the European Union by the end of its fiscal year on March 31.
Eisai predicted that the number of patients eligible for the drug in the United States would reach 100,000 within three years, gradually increasing from there in the medium to long term.
Dr. Erik Musiek, a Washington University neurologist at Barnes-Jewish Hospital, said the drug's cost "pleasantly surprised" him.
"Considering the marketplace and the fact that we have no other good disease-modifying treatments, I think it's in the ballpark of what I would expect," he said.
Initial patient access will be hampered by a variety of factors, including reimbursement restrictions imposed by Medicare, the United States' government insurance program for Americans aged 65 and older, who account for approximately 90% of those who are likely to be eligible for Leqembi.
"Without Centers for Medicare & Medicaid Services (CMS) and insurance coverage ... access for those who could benefit from the newly-approved treatment will only be available to those who can pay out-of-pocket," the Alzheimer's Association said in a statement.
Leqembi was approved through the FDA's accelerated review process, which expedites drug access based on its impact on underlying disease-related biomarkers thought to predict clinical benefit.
“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,” FDA neuroscience official Billy Dunn said in a statement.
CMS announced on Friday that current coverage restrictions for drugs approved through the accelerated pathway may be reconsidered based on its ongoing review of available data.
CMS stated that if the drug receives traditional FDA approval, it will provide broader coverage. According to Eisai officials, the company intends to submit data from a recent successful clinical trial involving 1,800 patients as the foundation for a full standard review of Leqembi.
The CMS decision was largely in response to Eisai and Biogen's previous Alzheimer's treatment. Aducanumab, marketed as Aduhelm, was granted accelerated approval in 2021 despite little evidence that it slowed cognitive decline and despite objections from the FDA's outside experts.
Aduhelm was initially priced at $56,000 per year before Biogen cut the price in half. Sales were only $4.5 million in the first nine months of 2022 due to limited acceptance and insurance coverage.
Lecanemab is intended for patients with mild cognitive impairment or early Alzheimer's dementia, a population that doctors believe is a small subset of the estimated 6 million Americans who suffer from the memory-robbing disease.
To receive the treatment, patients must first be tested for amyloid deposits in their brain, either through brain imaging or a spinal tap. They will also need to have regular MRI scans to check for brain swelling, a potentially serious side effect of this type of drug.
According to the label, doctors should exercise caution when giving blood clot preventers to lecanemab patients. According to an autopsy analysis published this week of a lecanemab patient who had a stroke and later died, this could pose a safety risk.
Lecanemab, which is administered via infusion, slowed the rate of cognitive decline in patients with early Alzheimer's disease by 27% when compared to a placebo in a large trial. In the trial, nearly 13% of patients receiving Leqembi experienced brain swelling.
According to Dr. Babak Tousi, a neuro-geriatrician at the Cleveland Clinic, the approval will make a "significant difference" in the field because it is based on biomarkers rather than symptoms.
"It's going to change how we make a diagnosis for Alzheimer's disease, with more accuracy," he said.
Tousi admitted that the drug's benefit will most likely be marginal. "However, it is a benefit that we were unable to achieve" prior to this approval.
(Source:www.usatoday.com)