Lecanemab

Generic Name: Lecanemab

Brand Names: Leqembi

Drug Type: Biotech

Chemical Formula: -

CAS Number: 1260393-98-3

Unique Ingredient Identifier: 12PYH0FTU9

Background: Lecanemab is a recombinant humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ), which are implicated in the pathophysiology of Alzheimer’s disease. Lecanemab works to reduce Aβ plaques and prevent Aβ deposition in the brain with high selectivity to Aβ protofibrils. In clinical trials, it significantly reduced brain Aβ plaques compared to placebo.

On January 6, 2023, lecanemab was granted accelerated approval by the FDA for the treatment of Alzheimer’s Disease. It was granted full FDA approval on July 6, 2023.

Indication: Lecanemab is indicated for the treatment of Alzheimer’s disease. Treatment with lecanemab 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.

Associated Conditions: Alzheimer's Disease (AD)

Associated Therapies: -

Clinical Trials

FDORA Changes to the FDA Accelerated Approval Program

The Consolidated Appropriations Act, enacted Dec 29, 2022, includes the Food and Drug Omnibus Reform Act (FDORA), enhancing FDA's authority, especially in the accelerated approval pathway for drugs treating serious conditions. FDORA mandates pre-approval agreement on post-approval study elements, increases transparency, and expedites withdrawal procedures for non-compliant drugs, aiming to ensure drug safety and efficacy.

finance.yahoo.com

2 years ago

Biogen Inc. (BIIB) Up 4.7% Since Last Earnings Report: Can It Continue?

Biogen Inc. reported Q1 2023 earnings of $3.40 per share, beating estimates, with sales at $2.46 billion, down 3% YoY. MS drug sales declined, but Spinraza and biosimilars showed resilience. The company expects revenue decline in 2023, focusing on cost savings and pipeline optimization, including deprioritizing certain R&D projects.

cnn.com

2 years ago

Alzheimer’s drug lecanemab receives accelerated approval amid safety concerns

The FDA granted accelerated approval for lecanemab, marketed as Leqembi, an Alzheimer’s drug showing potential to slow cognitive decline. Despite safety concerns like brain swelling and bleeding, it targets the disease's underlying process. Priced at $26,500/year, its Medicare coverage remains uncertain, mirroring restrictions on Aduhelm, its predecessor.

Drug Development Updates

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