Biogen (BIIB), Eisai Alzheimer Drug Gets FDA Panel Endorsement
Biogen BIIB and partner Eisai announced that an FDA advisory committee recommended sanctioning their supplementary biologics license application (“sBLA”) seeking full/traditional approval for their Alzheimer’s disease (“AD”) drug Leqembi (lecanemab).
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (“PCNSDAC”) voted unanimously that data from the confirmatory phase III CLARITY-AD study confirms the clinical benefit of Leqembi. The PCNSDAC also confirmed overall risk-benefit profile of Leqembi.
A final decision on the sBLA is expected by Jul 6, 2023.
The positive recommendation was based on 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.
An anti-amyloid beta protofibril antibody, Leqembi, was approved by the FDA under the accelerated pathway earlier this January. The accelerated approval was based on data from a phase II study (Study 201), which showed that treatment with lecanemab reduced the accumulation of amyloid beta (Aβ) plaque in the brain. Aβ plaque is a lesion in the brain that defines the neuropathological diagnosis of AD.
Biogen also announced that the NASDAQ halted trading of its common shares on Friday. This was likely due to the impact of the PCNSDAC’s recommendations on the company’s share price. The stock rose 4% in pre-market trading on Jun 12, following the positive recommendation from the FDA committee.
In the year so far, Biogen’s stock has risen 11.6% against the industry’s 7.8% decline.
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If Leqembi receives a traditional approval from the FDA, it also becomes eligible for a broader coverage under the United States government’s Medicare plan. Currently, Medicare restricts coverage of drugs like Leqembi, approved under the accelerated pathway, only to those enrolled in CMS-approved clinical studies.
Biogen developed lecanemab in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Though both companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.
Some other pharma companies like Eli Lilly LLY, Prothena PRTA and Roche RHHBY 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, Lilly will start filing regulatory submissions for the candidate in AD indication, including a regulatory filing with the FDA by June 2023-end.
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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