Eisai and Biogen Announce FDA Grants Breakthrough Therapy Designation to Lecanemab (BAN2401) for Alzheimer’s Disease

Alzheimer's (Image source: tecake.in)

June 24, 2021 /BioonBIOON/ -- Biogen and partner Eisai recently jointly announced that the U.S. Food and Drug Administration (FDA） Lecanemab (BAN2401) has been granted Breakthrough Therapy Designation (BTD), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD).

It is worth mentioning that earlier this month, a product jointly developed by the two partiesAnti-β-Amyloid Antibody Aduhelm (aducanumab) Approved by USFDAApproved, for the treatment of AD。Aduhelm represents the first-in-class drug approved for the treatment of AD, the first new therapy approved for AD since 2003, and the first therapy to target the underlying pathophysiology of AD, marking a major milestone advancement in AD treatment.

Breakthrough Therapy Designation (BTD) is an FDA new drug review pathway designed to expedite the development and review of new drugs intended to treat serious or life-threatening conditions, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. Drugs granted BTD status may receive during development, includingFDACloser guidance involving senior officials, along with eligibility for rolling review and potential priority review during the review process, to ensure that new treatment options are made available to patients in the shortest possible time.

FDAThe BTD granted to lecanemab is based on the recently published Phase 2bClinical TrialResults of (Study 201). The trial was conducted in 856 patients with mild Alzheimer's disease (AD) who had mild cognitive impairment (MCI) due to AD and confirmed amyloid pathology. This proof-of-concept study explored the effects of lecanemab treatment on reducing brain β-amyloid (Aβ) and clinical decline. In this study, pre-specified analyses showed that,Lecanemab at the highest dose consistently reduced multiple clinical andBiomarkerClinical decline at the endpoint.

In March 2021, Eisai and Biogen completed the enrollment of 1,795 patients with early Alzheimer's disease (AD) in the Clarity-AD study. The primary endpoint of the study is expected to be completed by the end of September 2022. Additionally, the Phase 3 clinical trial (AHEAD 3-45) is currently investigating lecanemab for the treatment of patients with preclinical AD, meaning they are clinically normal but have moderate or elevated amyloid levels in the brain. Open-label extension data from Study 201 have confirmed that,In patients newly treated with lecanemab, brain Aβ decreased in a time-dependent manner.The research results were presented at the 2021 Alzheimer's and Parkinson's Diseases ConferenceConference(Presented at the 2021 Alzheimer’s Disease and Parkinson’s Disease Conference.)

Alzheimer's disease (AD) is an irreversible, progressive brain disease that slowly destroys memory and thinking skills, and eventually impairs the ability to carry out simple tasks. Although the exact cause of AD is not fully understood, it is characterized by changes in the brain, including amyloid plaques and neurofibrillary (tau) tangles, which lead to the loss of neurons and their connections. These changes affect a person's memory and thinking abilities.

Aduhelm is the first treatment to target and modify the underlying disease process of AD.Researchers evaluated the efficacy of Aduhelm across three separate studies involving a total of 3,482 patients. These studies included double-blind, randomized, placebo-controlled dose-ranging studies in patients with AD. Patients treated with Aduhelm demonstrated a clear dose- and time-dependent reduction in amyloid-beta plaques, whereas no reduction in beta-amyloid plaques was observed in the control group.

These results supported the accelerated approval of Aduhelm, which was based on a surrogate endpoint of reduced amyloid-beta plaques in the brain, a hallmark of AD. In the studies, amyloid-beta plaques were quantified using positron emission tomography (PET) imaging to estimate amyloid-beta plaque levels in composite brain regions expected to be extensively affected by AD pathology, and compared with brain regions not expected to be affected by such pathology.

The prescribing information for Aduhelm includes a warning for amyloid-related imaging abnormalities (ARIA), which typically manifests as transient swelling in brain regions and usually resolves over time without causing symptoms, although some patients may experience headache, confusion, dizziness, visual changes, or nausea. Another warning for Aduhelm concerns the risk of hypersensitivity reactions, including angioedema and urticaria. The most common side effects of Aduhelm are ARIA, headache, falls, diarrhea, and confusion/delirium/altered mental status/disorientation. (Bioon.com)

Original Source:Eisai And Biogen Inc. Announce U.S. FDA Grants Breakthrough Therapy Designation For Lecanemab (BAN2401), An Anti-Amyloid Beta Protofibril Antibody For The Treatment Of Alzheimer's Disease