Drugs Pharma

FDA gives accelerated approval for Alzheimer’s drug

The FDA has granted accelerated approval for an intravenous drug to treat Alzheimer's Disease, according to a statement.

HQ Team

January 7, 2023: The FDA has granted accelerated approval for an intravenous drug to treat Alzheimer’s Disease, according to a statement.

Tokoyo-based Eisai Co., and Massachusetts-headquartered Biogen Inc., got the nod for its 100 mg/ml injection to fight aggregated amyloid beta (Aβ) for treating the disease.

Lecanemab, to be marketed as Leqembi, should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials, according to the FDA.

The medicine, to be injected once every two weeks, will be available during or before the week of January 23, 2023.

According to a joint statement, the approval is based on Phase II data that demonstrated that Leqembi reduced the accumulation of Aβ plaque in the brain, a defining feature of AD.

Phase III trial

Using data from the Phase III clinical trial, Eisai will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval.

An amyloid beta peptide is produced through the proteolytic processing of a transmembrane protein, amyloid precursor protein, by β- and γ-secretases. 

Aβ accumulation in the brain is an early toxic event in the pathogenesis of Alzheimer’s Disease, the most common form of dementia associated with plaques and tangles in the brain. 

A proteolytic enzyme catalyzes proteolysis, breaking down proteins into smaller polypeptides or single amino acids and spurring the formation of new protein products.

Memory impairment

Alzheimer’s is a neurodegenerative disease that causes progressive impairments in memory, language, and thinking.

It eventually results in a loss of ability to perform social and functional activities in daily life. Survival after a diagnosis of dementia due to AD generally ranges between four and eight years.

Life expectancy can be influenced by other factors, such as comorbid medical conditions, according to Alzheimer’s Association.

It is estimated that 6.2 million Americans age 65 and older are currently living with the Disease, and the number is projected to reach over 12 million by 2050 without interventions to prevent or slow the disease.

According to the FDA, there were no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than studied.

Substantial evidence

There is substantial evidence that lecanemab reduces Aβ plaques, and this reduction is reasonably likely to result in clinical benefit for patients.

It is appropriate to indicate the drug for Alzheimer’s Disease because it exists on a spectrum, and there may not be clear distinctions between one stage and another. 

Therefore, it will require clinical judgement for the prescriber regarding whether a patient is at an appropriate stage of disease for treatment and if there is a suggestion of clinical benefit that may warrant continued treatment despite the progression of the Disease. 

The most common adverse drug reactions with lecanemab are amyloid-related imaging abnormalities (AIRA), infusion-related reactions, and headaches.

“Substantial evidence of effectiveness has been established based on a reduction in amyloid beta plaque which supports accelerated approval of lecanemab for the treatment of Alzheimer’s disease,” according to the FDA.

Additional data

 The applicant proposes to submit additional data as soon as possible to fulfil the requirement to confirm the benefit clinical benefit of lecanemab for the treatment of Alzheimer’s Disease. 

ARIA will receive a warning in labelling describing the risk along with monitoring and dosing recommendations. Enhanced pharmacovigilance will be performed to characterize ARIA more fully in the practice setting. Infusion reactions will receive a warning in labelling. 

Eisai decided to price Leqembi treatment at $26,500 per year, aiming to promote broader patient access, reduce overall financial burden, and support health system sustainability, according to an Eisai statement.

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