FDA Approves Benzgalantamine for Treatment of Alzheimer Disease

The FDA has approved benzgalantamine (Zunveyl; Alpha Cognition), a cholinesterase inhibitor, to treat mild-to-moderate dementia associated with Alzheimer disease (AD) in adults. The novel oral therapy is designed to eliminate drug absorption in the gastrointestinal (GI) tract, which addresses tolerability concerns associated with other AD medications.¹

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“The approval of [benzgalantamine] is a pivotal moment in the fight against Alzheimer disease as it is only the second oral AD treatment to be approved in more than a decade. [Benzgalantamine] was designed to addresses a critical need for a tolerable and effective treatment that can potentially enhance patients' daily lives with improved long-term outcomes,” Michael McFadden, CEO of Alpha Cognition, said in a news release. “We are delighted, as this represents a major breakthrough in Alzheimer treatment, providing hope to millions of patients, families, and caregivers affected by this devastating disease.”¹

The approval was based on data that demonstrated the bioequivalence and tolerability of the drug compared with galantamine immediate- and extended-release medications. Investigators reported that there were minimal adverse events reported in the trials included in submission, which showed that GI-related adverse events occurred in less than 2% of participants and no cases of insomnia were reported. Further, investigators stated that the clinical trials for galantamine, the active molecule for benzgalantamine, have shown sustained improvements in cognitive function and quality of life over extended periods of time.¹

The company expects the drug to be available by prescription starting in the first quarter of 2025.¹

There have been many development in the AD space during July 2024, including a fast track designation for JNJ-2056 (AC Immune) and an approval for donanemab-azbt (Kisunla; Lilly). JNJ-2056 has the potential to reduce the effects of AD by targeting phosphorylated Tau. Currently, the drug is undergoing a phase 2b trial, ReTain, which is recruiting individuals who have preclinical AD without any clinical symptoms. The study includes 500 patients randomly assigned 1:1 to a single dose of the study immunization or the placebo for a maximum of 4 years.^2,3

The primary end point of the study will include cognitive decline, measured by the Preclinical AD Cognitive Composite 5 score, and the secondary end point will analyze the effect the vaccine has on the accumulation of Tau pathology measured by Tau PET imaging.²

On July 2, 2024, the FDA also approved donanemab for the treatment of early symptomatic AD, which includes individuals who have mild cognitive impairment and in the mild dementia stage of AD. Patients also need confirmed amyloid plaque. The drug is a once-monthly infusion and is the first and only amyloid therapy that supports stopping treatment once the plaque is removed.³

The results were based on the TRAILBLAZER-ALZ 2 (NCT04437511) study, a phase 3, randomized, double-blinded, placebo-controlled trail. The study was conducted at 277 sites in 8 countries, with 1736 individuals enrolled. The placebo and donanemab were administered every 4 weeks for up to 72 weeks. Investigators reported that the treatment slowed disease progression by approximately 35.1%.³

References

1. Alpha Cognition’s Oral Therapy Zunveyl Receives FDA Approval to Treat Alzheimer's Disease. News release. Alpha Cognition Inc. July 29, 2024. Accessed July 29, 2024. https://www.businesswire.com/news/home/20240729327804/en

2. Halpern L. JNJ-2056, Targeting Tau Protein, Receives FDA Fast Track Designation for Alzheimer Disease. Pharmacy Times. July 26, 2024. Accessed July 29, 2024. https://www.pharmacytimes.com/view/jnj-2056-targeting-tau-protein-receives-fda-fast-track-designation-for-alzheimer-disease

3. Gallagher A. FDA Approves Donanemab-Azbt for Early Symptomatic Alzheimer Disease. Pharmacy Times. July 2, 2024. Accessed July 29, 2024. https://www.pharmacytimes.com/view/fda-approves-donanemab-azbt-for-early-symptomatic-alzheimer-disease