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Biogen (BIIB), Eisai Get Full FDA Nod for Leqembi in Alzheimer's

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Biogen (BIIB - Free Report) and partner Eisai announced that the FDA granted full approval to their Alzheimer’s disease (“AD”) drug Leqembi (lecanemab).

Following the grant of full approval, Leqembi is the first and only approved anti-amyloid antibody treatment shown to reduce the rate of disease progression and slow cognitive impairment in the early and mild dementia stages of AD indication. The drug was initially granted accelerated approval for a similar indication in January.

Since Leqembi has received full/standard approval from the FDA, the Centers for Medicare and Medicaid Services (“CMS”) will make the medication available for a broader coverage under the United States government’s Medicare plan. Such coverage is crucial for a wider rollout of a treatment. Prior to full approval, Medicare coverage for the drug was restricted to patients who were enrolled in CMS-approved clinical studies.

In the year so far, Biogen’s stock has risen 2.9% against the industry’s 11.0% decline.

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The approval was expected, as last month, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (“PCNSDAC”) unanimously recommended granting full approval to Leqembi in treating AD. The FDA decision and PCNSDAC recommendation are based on positive data from the CLARITY AD study, which achieved its primary endpoint of reduction in Clinical Dementia Rating-Sum of Boxes (“CDR-SB”) scale by 27% compared with a placebo. The CDR-SB is a numerical scale that measures the severity of dementia symptoms. The study also achieved statistically significant results for its secondary endpoints.

Biogen has developed Leqembi in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Though the companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority. The companies also developed another anti-amyloid antibody, Aduhelm, which was approved by the FDA in June 2021 but failed to generate significant sales.

Some other pharma companies like Eli Lilly (LLY - Free Report) , Prothena (PRTA - Free Report) and Roche (RHHBY - Free Report) are also developing their antibody candidates targeting the AD indication.

Eli Lilly developed donanemab, an investigational antibody therapy, for AD. Last month, Lilly announced positive data from the phase III TRAILBLAZER-ALZ 2 study that showed that treatment with donanemab significantly slowed cognitive and functional decline in people with early symptomatic AD. Based on this result, Eli Lilly will start filing regulatory submissions in the coming weeks for the candidate in AD indication, including a regulatory filing with the FDA.

Prothena is evaluating multiple AD candidates in early-stage studies targeting AD indication. Prothena is evaluating PRX005, an investigational antibody that targets tau, a protein implicated in diseases — including AD, frontotemporal dementia, progressive supranuclear palsy, chronic traumatic encephalopathy and other tauopathies. Data from an early-stage study evaluating PRX005 is expected by the year end.

Prothena is also evaluating another investigational high-potency monoclonal antibody PRX012, designed to target a key epitope at the N-terminus of Aβ for treating AD, in a phase I study. PRTA plans to initiate an IND filing for PRX123, a dual Aβ-Tau vaccine treatment and prevention therapy for AD by the end of this year.

Roche’s phase III GRADUATE I and II studies on a key Alzheimer’s pipeline candidate, gantenerumab failed to meet the primary endpoint of slowing clinical decline in people with early AD in November 2022. The level of beta-amyloid removal by Roche’s gantenerumab was less than expected. Roche developed the candidate in collaboration with MorphoSys.


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Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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