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Anavex’s Innovative Alzheimer’s Therapy Blarcamesine Has Been Approved For EMA Marketing Authorization Application. What’s Next?

Anavex Life Sciences has initiated its European Medicines Agency marketing authorization application for the investigational small molecule therapy drug blarcamesine, bringing the drug one step closer to approval throughout the European Union and perhaps in the United States.

Author:Dexter Cooke
Reviewer:Hajra Shannon
Jun 14, 2024
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Anavex Life Scienceshas initiated its European Medicines Agency marketing authorization application for the investigational small molecule therapy drug blarcamesine, bringing the drug one step closer to approval throughout the European Union and perhaps in the United States.
Anavex has had quite an eventful few months. Following an extended analysis of blarcamesine (also known as Anavex 2-73), there is statistical evidence that the drug slows cognitive decline and reduces levels of brain plaque associated with early Alzheimer’s disease. That’s a significant finding for the Alzheimer’s community, given the ease of its orally available administration.
This evidence prompted the EMA to give Anavex the go-ahead to submit a marketing authorization application for blarcamesine as an Alzheimer’s therapy, bringing the innovative therapy one step closer to transforming the quality of life for millions of Europeans living with early symptoms of the disease.
“We look forward to working together with the team from EMA,” Anavex said in a press release. “We continue to work toward fulfilling our purpose of improving patients' lives with oral blarcamesine not requiring any complex additional procedures for the treatment of people with Alzheimer’s disease.”
As the company gears up to submit its application, here’s what to know and expect about the application process and blarcamesine’s foreseeable approval throughout the European Union.

Clinical Data Cleared Path for Marketing Authorization Application

An MAA requires the analysis of robust clinical trial data to demonstrate the quality, safety, and efficacy of a medication. In the European Union, a drug manufacturer must submit an MAA seeking approval to market and prescribe a drug throughout member states. The application must contain a detailed dossier outlining a product’s quality (raw materials and production process), safety (pharmacological, toxicological, and pharmacokinetic data), and efficacy (results of human clinical trials).
There are several approaches to filing an MAA. Anavexchose the centralized authorization procedure, allowing the company to submit a single application for marketing throughout the entire European Union. Once the company submits its application (expected sometime in 2024), it will be reviewed by representatives from all European Union member states and Iceland, Norway, and Liechtenstein, with a decision issued within 67 days.
While Anavex is still developing its MAA, blarcamesine is expected to be approved throughout the European Union given its positive Phase 2b/3 clinical trial results and past designation as an orphan drug (a pharmaceutical agent developed to treat certain rare conditions). Blarcamesine has exhibited a robust safety profile throughout all of its clinical trials, with its only side effects being transient mild dizziness.

The Potential Impact of Blarcamesine Approval in the European Union

On a continent where 1 in 5 individuals is 65 and older, the number of Europeans with Alzheimer’s disease is expected to reach 14 million by 2030. With the World Health Organization estimating that the annual cost of dementia and Alzheimer’s care in Europe has already reached $439 billion, [6] innovative therapies like blarcamesine may help ensure that an aging population has access to beneficial medicine.
As an orally available Alzheimer’s medication, blarcamesine is cheaper and less invasive than traditional therapies like monoclonal antibodies that are administered intravenously and require extensive testing like PET scans or spinal taps. This can ease the treatment process for Alzheimer’s patients and provide greater accessibility to Alzheimer’s medication by simply requiring a physician-assisted Alzheimer’s diagnosis for a prescription.
“There remains an urgent need for convenient once-daily oral treatment options for Alzheimer’s disease, and Anavex is moving forward to potentially addressing the preference for simple patient-centered administrations and shared decision-making,” said Christopher Missling, Ph.D., Anavex president and CEO.

What’s Next for Anavex?

With Anavex approved to submit an MAA to the EMA, many are wondering what to expect regarding blarcamesine’s approval in the U.S. by the Food and Drug Administration. Additional data will come from the the company’s ongoing two-year open-label ATTENTION-AD study of blarcamesine (expected before the end of 2024).
Following recently issued FDA guidelines for the development of early Alzheimer’s treatments that state cognitive measures (like blarcamesine’s slowing of Alzheimer's-related cognitive decline) could provide sufficient clinical endpoints for approval, Anavex is exploring a possible pathway of approval in the U.S. that is parallel to its initiated MAA in Europe.
Regardless of the path that Anavex takes toward approval, it’s evident that blarcamesine is on its way to market availability in the U.S. and Europe, a move that has the potential to transform the health outcomes of millions living with Alzheimer’s disease.
Stay up to date with Anavex (AVXL) here: https://finance.yahoo.com/quote/AVXL/
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Dexter Cooke

Dexter Cooke

Author
Dexter Cooke is an economist, marketing strategist, and orthopedic surgeon with over 20 years of experience crafting compelling narratives that resonate worldwide. He holds a Journalism degree from Columbia University, an Economics background from Yale University, and a medical degree with a postdoctoral fellowship in orthopedic medicine from the Medical University of South Carolina. Dexter’s insights into media, economics, and marketing shine through his prolific contributions to respected publications and advisory roles for influential organizations. As an orthopedic surgeon specializing in minimally invasive knee replacement surgery and laparoscopic procedures, Dexter prioritizes patient care above all. Outside his professional pursuits, Dexter enjoys collecting vintage watches, studying ancient civilizations, learning about astronomy, and participating in charity runs.
Hajra Shannon

Hajra Shannon

Reviewer
Hajra Shannona is a highly experienced journalist with over 9 years of expertise in news writing, investigative reporting, and political analysis. She holds a Bachelor's degree in Journalism from Columbia University and has contributed to reputable publications focusing on global affairs, human rights, and environmental sustainability. Hajra's authoritative voice and trustworthy reporting reflect her commitment to delivering insightful news content. Beyond journalism, she enjoys exploring new cultures through travel and pursuing outdoor photography
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