Anavex Life Sciences Corp., the clinical-stage biopharmaceutical company developing small molecule treatments for neurological diseases, recently outlined the positive results of a data analysis of its Phase 2b/3 clinical trial assessing the use of the investigational drug Anavex 2-73 (blarcamesine) as an oral treatment for the cognitive impacts of early-stage Alzheimer’s.
Results of this 48-week Phase 2b/3 clinical trial show that once-daily use of Anavex 2-73 significantly slows the rate of brain shrinkage and reduces levels of brain plaque-causing amyloid beta in blood, two common biomarkers of Alzheimer’s disease.
“These data are very exciting, particularly in a study that can demonstrate objective slowing of markers of neurodegeneration,” Michael Weiner, M.D., professor of radiology and biomedical imaging, medicine, psychiatry, and neurology at the University of California, San Francisco, and principal investigator with the Alzheimer’s Disease Neuroimaging Initiative, said in a press release.
With the success of Phase 2b/3, many are wondering when Anavex 2-73 will be approved in the United States and European Union for Alzheimer’s treatment. Here’s an overview of the approval process and when we can expect Anavex 2-73 to be available to the general population.
Anavex 2-73 European Union Approval
For a drug to be approved in the European Union, pharmaceutical companies must submit a market authorization to the European Medicines Agency, which will perform a robust evaluation of the drug based on its clinical trials and recommend whether to market it and in which countries.
In November 2023, the EMA’s Committee for Medicinal Products for Human Use approved Anavex to submit a marketing authorization application for blarcamesine as an oral treatment for Alzheimer’s disease.
Anavex has begun initiating this process and hopes to complete it in 2024. Once it’s completed, blarcamesine will undergo the review process and is expected to be granted direct market access throughout the European Union for oral Alzheimer’s treatments. All in all, this process may take over a year.
Anavex 2-73 FDA Approval
The U.S. Food and Drug Administration’s drug approval process is similar to the EMA, requiring clinical trials and confirmatory studies before a comprehensive review is conducted and approval is granted. While Anavex is currently moving forward with the application process in Europe, in the U.S., the company has decided to wait until the completion of the extended Attention-Ad long-term study to assemble an application package along with the Phase 2b/3 study. The Attention-Ad study is an ongoing two-year study that has followed patients who completed the previous phase and is expected to be finished sometime in 2024.
Although Anavex is waiting to move forward with its FDA application, things are still looking positive for the company and blarcamesine. The company recently expanded its patent coverage for Anavex 2-73, allowing the leading drug candidate to be studied as a treatment for anxiety, agitation, and insomnia.
Importance of ANAVEX 2-73 Approval
With very few oral medications that slow the cognitive decline of Alzheimer’s, approving the use of blarcamesine could potentially transform the lives of millions of people around the world living with early symptoms of the disease.
“There is hope that new therapies for Alzheimer’s that target the disease beyond amyloid that may slow progression of the disease for many people with the earliest forms of the disease,” said Marwan Noel Sabbagh, M.D., professor of neurology and chairman of Anavex’s scientific advisory board in a press release. “The advantage of blarcamesine (Anavex 2-73) is that it is a small oral molecule that exerts clinical benefits on cognition and neurodegeneration and could be appealing because of its route of administration and excellent safety profile.”
Once the Attention-Ad study is completed and Anavex 2-73 undergoes the FDA review process, the drug is expected to provide highly effective and affordable treatments that rank among the safest for Alzheimer’s medications.
As Anavex’s Attention-Ad study wraps up this year, the company is expected to apply for FDA approval soon after and bring Anavex 2-73 to market as fast as possible. Once approved, Anavex 2-73 has the potential to transform the quality of life for those living with Alzheimer’s as a safe, effective, and affordable oral treatment for early symptoms.
